# K041619: Bio Check Whole Blood/Plasma/Sermon Model #801116

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Dec 17, 2004 after 185 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 K023505 (2003). 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)
- K023505: VBL Serum Troponin I Test, Model 1001, Vancouver Biotech, Ltd. (2003) Summary page 2.

## Indications for use
The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K041619
Methodology: https://510kreport.com/methodology