# K030950: Vidas Troponin I (Tni), Model 30 445

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 16, 2003 after 82 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) Stratus CS Cardiac Troponin I Testpak: named in the summary without a submission number

## Indications for use
VIDAS Troponin I Assay is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique

Source page: https://510kreport.com/device/K030950
Methodology: https://510kreport.com/methodology