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Elecsys Troponin T Gen 5 STAT assay

A laboratory blood test from Roche Diagnostics that measures cardiac troponin T in lithium heparin plasma. It is sold with its own calibrator and control materials. FDA cleared it in January 2017 (510(k) K162895). FDA's decision summary describes it as an aid in diagnosing a heart attack (myocardial infarction) and says it runs on cobas system analyzers.

  • Product
  • In this atlas

Overview

Technical summary

FDA 510(k) K162895, decision date 2017-01-18 (received 2016-10-17), applicant Roche Diagnostics, product code MMI, device class 2, regulation number 862.1215, traditional clearance with a summary, decision Substantially Equivalent. The clearance covers the immunoassay and three related materials: the Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin and Elecsys Troponin T Gen 5 CalCheck 5. Neither the openFDA record nor the decision summary calls the assay high-sensitivity, so this page does not. The FDA summary is cite-only here. The sources read do not say who sells the assay today.

Product details

Type
Diagnostic
Model or formulation
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin and Elecsys Troponin T Gen 5 CalCheck 5, as the openFDA record names the cleared set
Version
Original clearance K162895; later changes are not described here

Intended-use sources

  1. Background FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

    Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
    Reuse basis
    FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

Claims and evidence

Context United States 510(k) clearance K162895 for a Roche cardiac troponin T blood test

Recipient
Recipient not specified
Population
Samples of lithium heparin plasma tested for cardiac troponin T on cobas system analyzers, to help diagnose a myocardial infarction (restated from the FDA decision summary). For prescription use and in vitro diagnostic use; results are to be used together with clinical signs and symptoms.
Care setting
Laboratory testing (the test runs on cobas system analyzers).
Geography
United States (decision by the US Food and Drug Administration).
Life stage
Not stated in the FDA record.
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision).
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Lithium heparin plasma samples
  • Use to help diagnose a myocardial infarction
  • Prescription use and in vitro diagnostic use
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration cleared 510(k) premarket notification K162895 on 18 January 2017, after receiving it on 17 October 2016. The openFDA record names Roche Diagnostics as applicant, lists the Elecsys Troponin T Gen 5 STAT Assay together with its CalSet, PreciControl Troponin and CalCheck 5 materials, and gives product code MMI, device class 2, regulation number 862.1215, a traditional clearance with a summary, and the decision Substantially Equivalent (code SESE). FDA's decision summary describes the immunoassay as a quantitative measurement of troponin T from the heart, made on lithium heparin plasma, that is meant to help diagnose myocardial infarction, for use on cobas system analyzers. Its special conditions for use are prescription use and in vitro diagnostic use. It adds that troponin readings must be read alongside the patient's signs and symptoms. It gives claimed cut-offs taken from the upper 99th-percentile reference value in apparently healthy adults: 19 ng/L for all, 22 ng/L for men and 14 ng/L for women.

    Applies to Recipient not specified
    • Samples of lithium heparin plasma tested for cardiac troponin T on cobas system analyzers, to help diagnose a myocardial infarction (restated from the FDA decision summary). For prescription use and in vitro diagnostic use; results are to be used together with clinical signs and symptoms.
    • Laboratory testing (the test runs on cobas system analyzers).
    • United States (decision by the US Food and Drug Administration).
    • Not stated in the FDA record.
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision).
    Certainty method
    Not assessed
    Limitations
    The decision summary and the openFDA record do not call the assay high-sensitivity, so this page does not. The summary says that in women a positive result is less often a true heart attack at 14 ng/L, the threshold set for women, than at 19 ng/L, and that, at the lower end of the 95% interval, as many as 69%, 82% and 78% of the positive results in women are not myocardial infarction (the summary does not say here which results those three figures describe). It sets what the test is for; it is not evidence of how well the test performs in a given patient. The calibrator and control materials in the same clearance are not described. The FDA summary is cite-only here, so its wording is restated and not quoted. openFDA data are unvalidated.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (26)

    1. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].k_number
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    2. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].device_name
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    3. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].applicant
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    4. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].product_code
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    5. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].decision_date
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    6. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].decision_code
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    7. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].decision_description
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    8. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].date_received
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    9. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].clearance_type
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    10. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].statement_or_summary
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    11. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].advisory_committee_description
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    12. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].openfda.regulation_number
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    13. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].openfda.device_class
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    14. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].openfda.medical_specialty_description
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    15. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      results[0].openfda.device_name
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    16. Supports FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · 510(k): K162895

      Locator
      meta.last_updated
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-510k-k162895.json. It includes a contact name and address that FDA publishes; records here do not repeat them.

    17. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.2 Indication(s) for use
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    18. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.2 Indication(s) for use (quote 2)
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    19. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.2 Indication(s) for use (quote 3)
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    20. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, C. Measurand
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    21. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.3 Special conditions for use
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    22. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.3 Special conditions for use (quote 2)
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    23. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.3 Special conditions for use (quote 3)
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    24. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.3 Special conditions for use (quote 4)
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    25. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, H.3 Special conditions for use (quote 5)
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

    26. Supports FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.

      Locator
      Decision summary, M.4 Clinical cut-off
      How it applies
      FDA decision summary.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-k162895-summary.pdf).

Authorization

Regulatory decision: Elecsys Troponin T Gen 5 STAT assay

Applies to Recipient not specified
  • Samples of lithium heparin plasma tested for cardiac troponin T on cobas system analyzers, to help diagnose a myocardial infarction (restated from the FDA decision summary). For prescription use and in vitro diagnostic use; results are to be used together with clinical signs and symptoms.
  • Laboratory testing (the test runs on cobas system analyzers).
  • United States (decision by the US Food and Drug Administration).
  • Not stated in the FDA record.
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision).
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K162895
Product code
MMI
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Elecsys Troponin T Gen 5 STAT Assay, with its CalSet, PreciControl Troponin and CalCheck 5 materials, as cleared in K162895
Indication
Quantitative measurement of cardiac troponin T in lithium heparin plasma, meant to help diagnose myocardial infarction, for use on cobas system analyzers; for prescription use and for in vitro diagnostic use; results are to be read alongside clinical signs and symptoms; in women a positive result is less often a true heart attack at the 14 ng/L cut-off than at 19 ng/L (FDA decision summary, restated).
Basis
The US Food and Drug Administration cleared 510(k) premarket notification K162895 on 18 January 2017, after receiving it on 17 October 2016. The openFDA record names Roche Diagnostics as applicant, lists the Elecsys Troponin T Gen 5 STAT Assay together with its CalSet, PreciControl Troponin and CalCheck 5 materials, and gives product code MMI, device class 2, regulation number 862.1215, a traditional clearance with a summary, and the decision Substantially Equivalent (code SESE). FDA's decision summary describes the immunoassay as a quantitative measurement of troponin T from the heart, made on lithium heparin plasma, that is meant to help diagnose myocardial infarction, for use on cobas system analyzers. Its special conditions for use are prescription use and in vitro diagnostic use. It adds that troponin readings must be read alongside the patient's signs and symptoms. It gives claimed cut-offs taken from the upper 99th-percentile reference value in apparently healthy adults: 19 ng/L for all, 22 ng/L for men and 14 ng/L for women.

Limitations. The decision summary and the openFDA record do not call the assay high-sensitivity, so this page does not. The summary says that in women a positive result is less often a true heart attack at 14 ng/L, the threshold set for women, than at 19 ng/L, and that, at the lower end of the 95% interval, as many as 69%, 82% and 78% of the positive results in women are not myocardial infarction (the summary does not say here which results those three figures describe). It sets what the test is for; it is not evidence of how well the test performs in a given patient. The calibrator and control materials in the same clearance are not described. The FDA summary is cite-only here, so its wording is restated and not quoted. openFDA data are unvalidated.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:elecsys-troponin-t-gen5
Content hash
2b5d2ef1ea4f7a1c55e2321245217133452522dcfe8dea7c4ccaedea9aa6edff