# K984105: Elecsys Troponin T Stat Test

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 8, 1998 after 21 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961500 (1996). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961500: Elecsys Troponin T, Boehringer Mannheim Corp. (1996) Summary page 2.

## Most influential descendants
- K040733: Elecsys Troponin T Stat Test (2004), 10 descendants of its own
- K051752: Roche Elecsys Troponin T Stat  (Short Turnaround Time) (2005), 9 descendants of its own
- 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

## Recalls of this device
- Jan 31, 2006 · Not classified · Z-0512-06: A false negative result may be reported.
- Apr 25, 2003 · Not classified · Z-0870-03: Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

## Indications for use
Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles, TnT originating exclusively from the myocardium (cardiac TnT, molecular weight 39.7 kD) clearly differs from skeletal muscle TnT. As a result of its high tissue-specificity, cardiac troponin T (¢TnT) is a cardiospecific, highly sensitive marker for myocardial damage. In cases of acute myocardial infarction, troponin T levels in serum rise about 3-4 hours after the occurrence of cardiac symptoms and can remain elevated for up to 14 days. The determination of ¢TnT in serum is an important component in the diagnosis of myocardial ischemia, e.g. AMI and myocarditis, as well as in monitoring the course of unstable angina pectoris and assessing the associated risk. -6 Comparative studies on 770 patients confirm the prognostic utility of cTnT. "It has also been shown that cTnT-positive patients benefit particularly from antithrombotic therapy strategies (e.g. low molecular weight heparin, BPIIb/IIIa antagonists). 89 Elevated serum cTnT values are detectable in about 30% of patients suffering from renal failure (e.g. chronic hemodialysis patients). The cTnT detected in these patients is of cardiac origin. It has been demonstrated e.g. with RT-PCR, that cTnT is not expressed in regenerated skeletal musculature of patients with renal failure. 111 Clinical data increasingly demonstrate that such patients have a high risk of subsequently suffering cardiovascular complications. 12-15

Source page: https://510kreport.com/device/K984105
Methodology: https://510kreport.com/methodology