# K052082: Ferritin on the Access Immunoassay Systems, Model 33020

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 19, 2005 after 17 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
Longest line of descent: 1 generation back to K926221 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
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 1.

## Most influential descendants
- K234052: Access Ferritin (2024), 0 descendants 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.

## 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.

Source page: https://510kreport.com/device/K052082
Methodology: https://510kreport.com/methodology