# K021229: Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 28, 2002 after 71 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000196 (2000). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000196: Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316, Beckman Coulter, Inc. (2000)

## Most influential descendants
- K231832: Access Myoglobin (2023), 0 descendants of its own
- K080481: Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators (2009), 0 descendants of its own
- K062737: Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer (2007), 0 descendants of its own

## Recalls of this device
- Sep 27, 2007 · Not classified · Z-1396-2009: Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determin

## Indications for use
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

Source page: https://510kreport.com/device/K021229
Methodology: https://510kreport.com/methodology