# K092740: Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 5, 2010 after 178 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 K972232 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972232: Abbott Axsym Folate, Abbott Laboratories (1997) Summary page 2.

## Most influential descendants
- K192586: LIAISON® Folate (2020), 0 descendants of its own

## Indications for use
The ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum and plasma on the ARCHITECT i System. Folate measurements are used in the diagnosis and treatment of megaloblastic anemia. The ARCHITECT Folate Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of folate in human serum and plasma. The ARCHITECT Folate Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.

Source page: https://510kreport.com/device/K092740
Methodology: https://510kreport.com/methodology