# K051292: Elecsys RBC Folate Hemolyzed Reagent

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 17, 2005 after 30 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: 2 generations back to K935286 (1994). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay, Roche Diagnostics/Boehringer Mannheim GmbH (1998) Summary page 1.

## Most influential descendants
- K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys (2009), 7 descendants of its own
- K111506: Elecsys Precicontrol Varia 3 (2011), 3 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K103716: Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset (2011), 1 descendant of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own

## Indications for use
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this devices are used in the diagnosis and treatment of anemias. The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Source page: https://510kreport.com/device/K051292
Methodology: https://510kreport.com/methodology