# Elecsys Troponin T Gen 5 STAT assay

Product · id `cardio:elecsys-troponin-t-gen5` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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).

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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).
- 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
- Sources:
  1. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].k\_number. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  2. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].device\_name. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  3. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].applicant. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  4. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].product\_code. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  5. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  6. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  7. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].decision\_description. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  8. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].date\_received. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  9. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].clearance\_type. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  10. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].statement\_or\_summary. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  11. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].advisory\_committee\_description. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  12. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].openfda.regulation\_number. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  13. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].openfda.device\_class. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  14. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].openfda.medical\_specialty\_description. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  15. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: results\[0\].openfda.device\_name. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: openFDA record field.
  16. Supports: FDA 510(k) premarket notification K162895: Elecsys Troponin T Gen 5 STAT Assay and related calibrator and control materials (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) <https://api.fda.gov/device/510k.json?search=k_number:K162895>
     Locator: meta.last\_updated. Retrieved 2026-10-15T13:49:00Z. Source state: Current. Snapshot hash: 51d3e676c79a63c9b7d7501c1632f1735ec5e6ad6be7b41673571337d1a131ee.
     How it applies: Statement in the cited record.
  17. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.2 Indication(s) for use. Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  18. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.2 Indication(s) for use (quote 2). Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  19. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.2 Indication(s) for use (quote 3). Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  20. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, C. Measurand. Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  21. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.3 Special conditions for use. Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  22. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.3 Special conditions for use (quote 2). Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  23. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.3 Special conditions for use (quote 3). Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  24. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.3 Special conditions for use (quote 4). Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  25. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, H.3 Special conditions for use (quote 5). Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.
  26. Supports: FDA 510(k) substantial equivalence determination decision summary for K162895 (Elecsys Troponin T Gen 5 STAT) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext. The decision summary of the FDA 510(k) database.) <https://www.accessdata.fda.gov/cdrh_docs/reviews/K162895.pdf>
     Locator: Decision summary, M.4 Clinical cut-off. Retrieved 2026-10-15T13:55:54Z. Source state: Current. Snapshot hash: 8df8742bb9508cf0c6d4dbc03562fa03dc268b9f9070dd8a74731c0ee607468a.
     How it applies: FDA decision summary.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-k162895`

- Product: Elecsys Troponin T Gen 5 STAT assay (`cardio:elecsys-troponin-t-gen5`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Clearance, 2017-01-18
- Product version: Elecsys Troponin T Gen 5 STAT Assay, with its CalSet, PreciControl Troponin and CalCheck 5 materials, as cleared in K162895
- Pathway: 510(k)
- Submission: K162895
- Product code: MMI
- Device class: II
- 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).
- Jurisdictions: United States; note: United States
- Applies to: 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).
- Basis: claim `cardio:claim-fda-k162895-clearance`

## Connected pages

- Measures cardiac troponin T: Cardiac troponin blood test (`cardio:cardiac-troponin`)
- Filed under this front: Diagnostics and imaging (`cardio:front-diagnostics-and-imaging`)

## Provenance

Content hash: 2b5d2ef1ea4f7a1c55e2321245217133452522dcfe8dea7c4ccaedea9aa6edff
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15