# K022946: Lifesign MI Myoglobin/Troponin I Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Oct 8, 2002 after 34 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
Longest line of descent: 1 generation back to K981882 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981882: Cardiac Status CK-MB/Myoglobin/Troponin I Rapid Test, Princeton BioMeditech Corp. (1998) Summary page 1.

## Indications for use
The LifeSign MI" MyoglobidTroponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of myoglobin and troponin I in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

Source page: https://510kreport.com/device/K022946
Methodology: https://510kreport.com/methodology