# K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jan 18, 2017 after 93 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931172 (1993). 25 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051752: Roche Elecsys Troponin T Stat  (Short Turnaround Time), Roche Diagnostics (2005) Summary page 8.
- K961500: Elecsys Troponin T, Boehringer Mannheim Corp. (1996) Summary page 8.
- K082699: Elecsys Troponin I and Troponin I Stat Test Systems, Roche Diagnostics (2009) Summary page 8.
- K122242: Elecsys CA 15-3 II Calcheck 5, Roche Diagnostics (2012) Summary page 8.

## Most influential descendants
- K191595: ARCHITECT STAT High Sensitivity Troponin-I (2019), 2 descendants of its own
- K202525: Alinity i STAT High Sensitivity Troponin-I (2022), 1 descendant of its own
- K230994: Alinity i STAT High Sensitivity Troponin-I (2023), 0 descendants of its own
- K201441: Elecsys Troponin T Gen 5 (2021), 0 descendants of its own
- K190675: Dimension EXL High-Sensitivity Troponin I (TNIH) Assay (2019), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. CalSet Troponin T Gen 5 STAT is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers.

Source page: https://510kreport.com/device/K162895
Methodology: https://510kreport.com/methodology