# K060875: Abbott Axsym Troponin-I Adv

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 14, 2006 after 76 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) Beckman Coulter Access AccuTnI assay: named in the summary without a submission number

## Recalls of this device
- Jan 19, 2009 · Not classified · Z-1051-2009: Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

## Indications for use
The AXSYM Troponin-I ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-l CcTnI) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

Source page: https://510kreport.com/device/K060875
Methodology: https://510kreport.com/methodology