# K974075: Access Troponin I Reagents on the Access Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Nov 10, 1997 after 12 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Baxter Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Most influential descendants
- K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303 (2006), 2 descendants of its own
- K252393: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (2025), 0 descendants of its own
- K241165: Atellica® IM High-Sensitivity Troponin I (TnIH) (2024), 0 descendants of its own

## Indications for use
The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum and plasma (EDTA), using the ACCESS® Immunoassay System.

Source page: https://510kreport.com/device/K974075
Methodology: https://510kreport.com/methodology