# K041596: Architect Stat CK-MB Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Fisher Diagnostics
- Decided: Jul 21, 2004 after 37 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- 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 K935924 (1994). 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)
- K935924: Axsym CK-MB, Abbott Laboratories (1994) Summary page 1.

## Indications for use
ARCHITECT STATCK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).

Source page: https://510kreport.com/device/K041596
Methodology: https://510kreport.com/methodology