# K926221: Access Ferritin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jan 13, 1993 after 34 days
- Product code: JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin)
- Device class: 2
- Regulation: 21 CFR 866.5340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 5 cite it directly.
0 of 14 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
- K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) (1997), 5 descendants of its own
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own
- K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (2014), 1 descendant of its own
- K080634: Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495 (2008), 1 descendant of its own

## Recalls of this device
- Mar 10, 2017 · Class II · Z-1833-2017: Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

Source page: https://510kreport.com/device/K926221
Methodology: https://510kreport.com/methodology