# K041811: Abbott Axsym Troponin-I Adv

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 10, 2004 after 66 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (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
- Apr 23, 2007 · Not classified · Z-1023-2007: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instru
- Sep 8, 2006 · Not classified · Z-0117-2007: Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.

## Indications for use
The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) The AxSYM Troponin-I ADV Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM System (reagents, calibrators, and instrument) when used for the quantitative measurement of cardiac troponin-I in human serum or plasma.

Source page: https://510kreport.com/device/K041811
Methodology: https://510kreport.com/methodology