# K984301: Abbott Architect Folate

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 5, 1999 after 65 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
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. The FDA summary names its predicate without a number.
- (no number) BioRad Quantaphase II® Folate Radioassay: named in the summary without a submission number

## Indications for use
The Abbott ARCHITECT™ Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells on the Abbott ARCHITECT™ i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.

Source page: https://510kreport.com/device/K984301
Methodology: https://510kreport.com/methodology