# K023505: VBL Serum Troponin I Test, Model 1001

- Pathway: 510(k) (Traditional)
- Applicant: Vancouver Biotech, Ltd.
- Decided: Mar 31, 2003 after 164 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K041619: Bio Check Whole Blood/Plasma/Sermon Model #801116 (2004), 0 descendants of its own
- K042227: Instant-View Troponin I Test (2004), 0 descendants of its own

## Indications for use
The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K023505
Methodology: https://510kreport.com/methodology