# K993353: Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 6, 1999 after 62 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: 1 generation back to K973616 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973616: Troponin I Assay for the Bayer Immuno 1 System, Bayer Corp. (1997) Summary page 1.

## Indications for use
This in vitro diagnostic method intended to quantitatively measure the concentration of cardiac Troponin 1 (Tnl) in human serum and plasma (lithium heparin) using the Bayer Immuno 1 system. When used in conjunction with other clinical data, such as presenting symptoms and diagnostic procedures, measurements of cardiac Tnl aids in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revalcularization procedures. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K993353
Methodology: https://510kreport.com/methodology