# K033155: Biocentrex Cardiac Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biocentrex
- Decided: Jan 12, 2004 after 104 days
- Product code: MYT (Biosensor, Immunoassay, 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: 2 generations back to K010429 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021814: Accutni and Accutni  Calibrators on the Access Immunoassay Systems, Model #33340, 33345, Beckman Coulter, Inc. (2002) Summary page 1.
- K000716: Access CK-MB on the Access Immunoassay Analyzer, Beckman Coulter, Inc. (2000) Summary page 1.
- K951634: Access Myoglobin Reagents, Bio-Rad Laboratories, Inc. (1995) Summary page 1.

## Indications for use
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.

Source page: https://510kreport.com/device/K033155
Methodology: https://510kreport.com/methodology