# K060774: Folate on the Access Immunoassay Systems, Model A14208

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 21, 2006 after 30 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- 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 K932887 (1993). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932887: Access Folate Assay, Beckman Coulter, Inc. (1993) Summary page 1.
- K943149: Access Red Blood Cell Folate Assay, Beckman Coulter, Inc. (1994) Summary page 1.
- K955434: Access Folate Assay (Modification), Beckman Coulter, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K111952: Access Folate Calibrators on the Access Immunoassay Systems Model A98033 (2011), 1 descendant of its own
- K223590: Access Folate Assay (2023), 0 descendants of its own

## Recalls of this device
- Jul 24, 2012 · Class II · Z-0046-2013: Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

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

Source page: https://510kreport.com/device/K060774
Methodology: https://510kreport.com/methodology