# K994439: Access CK-MB on the Access Immunoassay Analyzer, Models 33300, 33305, 33309, 33306

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 14, 2000 after 22 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The AcCEss® CK-MB assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.

Source page: https://510kreport.com/device/K994439
Methodology: https://510kreport.com/methodology