# K240987: Access sTfR

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 3, 2024 after 84 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926221 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080634: Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495, Beckman Coulter, Inc. (2008) Summary page 4.

## Indications for use
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD). This assay may also be used in conjunction with an Access Ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.

Source page: https://510kreport.com/device/K240987
Methodology: https://510kreport.com/methodology