# K042227: Instant-View Troponin I Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Nov 19, 2004 after 94 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 1.

## Indications for use
The INSTANT-VIEW® Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting. The INSTANT-VIEW® Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.

Source page: https://510kreport.com/device/K042227
Methodology: https://510kreport.com/methodology