# K992365: Aia-Pack Folate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Aug 10, 1999 after 26 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 30, 2018 · Class II · Z-0672-2019: 
- Sep 1, 2006 · Not classified · Z-0082-2007: Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument

## Indications for use
AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AlA System analyzers.

Source page: https://510kreport.com/device/K992365
Methodology: https://510kreport.com/methodology