# K103716: Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: May 12, 2011 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
Longest line of descent: 8 generations back to K931172 (1993). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys, Roche Diagnostics Corp. (2009) Summary page 3.

## Most influential descendants
- K233060: Elecsys Folate III (2024), 0 descendants of its own

## Indications for use
(1) Eleesys Folate R-BC Assay: Measurements obtained by this device are used in the diagnosis and treatment of anemias on the Eleesys and cobas e immunoassay analyzers. For in vitro diagnostic use. (2) Elecsys Folate RBC CalSet: Elecsys Folate RBC CalSet is used for calibrating the Elecsys Folate RBC assay on the Eleesys and cobas e immunmoassay analyzers. For in vitro diagnostic use. (3) Eleesys Folate RBC CaiCheck: Eleesys Folate RBC CaiCheck is used for the verification of the calibration established by the Elecsys Folate RBC reagent on the indicated Elecsys and cobas e inmmoassay analyzers. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K103716
Methodology: https://510kreport.com/methodology