# K091332: Aia-Pack RBC Folate

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Oct 2, 2009 after 149 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: 1 generation back to K010050 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010050: Advia Centaur and Acs: 180 Folate Immunoassay, Bayer Diagnostics Corp. (2001) Summary page 2.

## Indications for use
Tosoh AIA-PACK RBC FOLATE is designed for in vitro diagnostic use only for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (Heparin or EDTA) samples on TOSOH AIA system analyzer. Measurement of RBC Folate is used in the diagnosis and treatment of anemia.

Source page: https://510kreport.com/device/K091332
Methodology: https://510kreport.com/methodology