# K961500: Elecsys Troponin T

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 11, 1996 after 54 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
No predicates in its family tree.
56 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CARDIAC T® Troponin T Enzymun Test: named in the summary without a submission number

## Most influential descendants
- K962575: Elecsys Precicontrol Cardiac (1996), 52 descendants of its own
- K983492: Boehringer Mannheim Elecsys Presicontrol Cardiac (1998), 51 descendants of its own
- K032089: Roche Diagnostics Elecsys Precicontrol Cardiac (2003), 41 descendants of its own
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset (2008), 20 descendants of its own
- K033937: Elecsys Precicontrol Multianalyte (2004), 19 descendants of its own

## Indications for use
For the in vitro quantitative determination of troponin T in human serum and plasma. Diagnosis of acute myocardial infarction (AMI) is generally based on the presence of at least two of three classic findings: clinical symptoms, diagnostic ECG, and serological findings of abnormal levels of total CK, LD or their isoenzymes. Often, due to the presence of clinical symptoms and changes in the ECG, the CK, CK-MB, LD and LD1 serve primarily to confirm and monitor the course of the infarction. At other times, when chest pain is atypical, or ECG changes are non-diagnostic or absent, these markers provide important diagnostic information. Limitations to these serum markers include a relatively narrow diagnostic window, difficulty in interpreting small increases and a lack of cardiac specificity. Troponin T can be an effective serum marker whose cardiac specificity and wide diagnostic window makes it a valuable tool in the diagnosis of AMI. Troponin T has been shown to be elevated in all patients with AMI who are diagnosed by World Health Organization (WHO) criteria. Troponin T frequently appears in serum as early as one to three hours after the onset of pain. The sensitivity of troponin T reaches 100% within hours and remains at a high sensitivity level until day five. After 48 hours the CK-MB assay is frequently of little diagnostic value. Troponin T also remains elevated longer than total LD. Its levels can be measured for up to 14 days. Thus, the diagnostic window is broader due to the length of time troponin T is elevated in serum. The time interval of elevation in serum ranges from three hours to > 14 days. The specificity and sensitivity of troponin T measurements aid in both the early and late diagnosis of AMI. Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage. In cases of AMI with minimal cardiac damage, low elevations of CK and CK-MB are difficult to interpret due to the presence of normal levels of these enzymes in the blood, and their lack of cardiac specificity. The specificity of troponin T to cardiac tissue is of value in these difficult patients.

Source page: https://510kreport.com/device/K961500
Methodology: https://510kreport.com/methodology