# K063243: Vidas Troponin I Ultra (Tniu) Assay, Model 30 448

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 14, 2007 after 414 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) Dimension RxL® Cardiac Troponin I (CTNI) Assay: named in the summary without a submission number

## Indications for use
VIDAS® Troponin I Ultra is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. VIDAS Troponin I Ultra is intended to be used as an aid in the diagnosis of myocardial infarction.

Source page: https://510kreport.com/device/K063243
Methodology: https://510kreport.com/methodology