# K234052: Access Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 20, 2024 after 90 days
- Product code: JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin)
- Device class: 2
- Regulation: 21 CFR 866.5340
- 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 K926221 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926221: Access Ferritin Assay, Bio-Rad Laboratories, Inc. (1993) Summary page 4.
- K052082: Ferritin on the Access Immunoassay Systems, Model 33020, Beckman Coulter, Inc. (2005) Summary page 4.

## Indications for use
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

Source page: https://510kreport.com/device/K234052
Methodology: https://510kreport.com/methodology