# K973616: Troponin I Assay for the Bayer Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 5, 1997 after 73 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Dade Stratus® Troponin I kit: named in the summary without a submission number

## Most influential descendants
- K993353: Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System) (1999), 0 descendants of its own

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure the concentration of cardiac Troponin I (TnI) 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, measurement of cardiac Troponin I aids in the diagnosis of acute myocardial infarction (AMI). This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K973616
Methodology: https://510kreport.com/methodology