# K000196: Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 18, 2000 after 28 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K021229: Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244 (2002), 3 descendants of its own
- 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
- K012040: Ramp Myoglobin Assay (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K000196
Methodology: https://510kreport.com/methodology