# K161646: Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Nov 4, 2016 after 142 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Diazyme Folate Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of folate in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. For in-vitro diagnostic use only. The Diazyme Folate Calibrator Set is intended for use in the calibration of the Diazyme Folate Assay. For in vitro diagnostic use only. The Diazyme Folate Control Set is intended for use as quality controls for the Diazyme Folate Assay. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K161646
Methodology: https://510kreport.com/methodology