# K030012: CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 17, 2003 after 15 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 K000716 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K000716: Access CK-MB on the Access Immunoassay Analyzer, Beckman Coulter, Inc. (2000)

## Most influential descendants
- K234005: Access CK-MB (2024), 0 descendants of its own

## 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 and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.

Source page: https://510kreport.com/device/K030012
Methodology: https://510kreport.com/methodology