# K223590: Access Folate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 23, 2023 after 265 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- 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 K932887 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060774: Folate on the Access Immunoassay Systems, Model A14208, Beckman Coulter, Inc. (2006) Summary page 4.
- K111952: Access Folate Calibrators on the Access Immunoassay Systems Model A98033, Beckman Coulter, Inc. (2011) Summary page 4.

## Indications for use
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia. Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.

Source page: https://510kreport.com/device/K223590
Methodology: https://510kreport.com/methodology