# K000716: Access CK-MB on the Access Immunoassay Analyzer

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 20, 2000 after 17 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030012: CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372 (2003), 1 descendant of its own
- K234005: Access CK-MB (2024), 0 descendants of its own
- K033155: Biocentrex Cardiac Panel (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K000716
Methodology: https://510kreport.com/methodology