# K014105: Spectral's Troponin I

- Pathway: 510(k) (Traditional)
- Applicant: Spectral Diagnostics, Inc.
- Decided: Feb 1, 2002 after 50 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of cardiac troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

Source page: https://510kreport.com/device/K014105
Methodology: https://510kreport.com/methodology