# K993309: Bayer Diagnostics Acs:180 and Advia Centaur Troponin I Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 6, 1999 after 63 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Bayer Diagnostics ACS:180 Troponin I Immunoassay: named in the summary without a submission number

## Indications for use
For the quantitative determination of cardiac troponin I in serum or heparinized plasma using the Bayer Diagnostics ACS:180° and ADVIA® Centaur™ Automated Chemiluminescent Systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction 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 revascularization procedures.

Source page: https://510kreport.com/device/K993309
Methodology: https://510kreport.com/methodology