# K111952: Access Folate Calibrators on the Access Immunoassay Systems Model A98033

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 19, 2011 after 39 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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: 2 generations back to K932887 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.

## Most influential descendants
- K223590: Access Folate Assay (2023), 0 descendants of its own

## Recalls of this device
- Jul 24, 2012 · Class II · Z-0047-2013: 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 Calibrators are intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K111952
Methodology: https://510kreport.com/methodology