# K974103: Abbott Axsym Troponin-I

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 25, 1997 after 25 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- 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) Dade Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Recalls of this device
- Mar 26, 2004 · Not classified · Z-0782-04: An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.

## Indications for use
Abbott AxSYM® Troponin-I is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the Abbott AxSYM System. Measurements obtained by this device are used to assist in the diagnosis of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K974103
Methodology: https://510kreport.com/methodology