# K082699: Elecsys Troponin I and Troponin I Stat Test Systems

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 19, 2009 after 338 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931172 (1993). 13 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021814: Accutni and Accutni  Calibrators on the Access Immunoassay Systems, Model #33340, 33345, Beckman Coulter, Inc. (2002) Summary page 4.
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset, Roche Diagnostics (2008) Summary page 4.

## Most influential descendants
- 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 (2017), 8 descendants of its own
- 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

## Recalls of this device
- Apr 7, 2021 · Class II · Z-1596-2021: Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on th
- Apr 7, 2021 · Class II · Z-1595-2021: Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on th
- Mar 12, 2012 · Not classified · Z-1388-2012: An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may 
- Mar 12, 2012 · Not classified · Z-1387-2012: An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may 

## Indications for use
Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin i assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers. Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers. Elecsys PreciControl Troponin is used for quality control of the Elecsys Troponin-I and Elecsys Troponin I STAT immunoassays on the Elecsys and MODULAR Analytics El170 Analyzers. Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the Elecsys and MODULAR Analytics El 70 analyzers. Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers.

Source page: https://510kreport.com/device/K082699
Methodology: https://510kreport.com/methodology