# K233060: Elecsys Folate III

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 17, 2024 after 266 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: 9 generations back to K931172 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103716: Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset, Roche Diagnostics (2011) Summary page 4.

## Indications for use
Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K233060
Methodology: https://510kreport.com/methodology