# K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics/Boehringer Mannheim GmbH
- Decided: Aug 25, 1998 after 84 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 K935286 (1994). 1 ancestor in all.
9 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)
- K935286: Quantaphase II B12/Folate, Bio-Rad (1994) Summary page 1.

## Most influential descendants
- K051292: Elecsys RBC Folate Hemolyzed Reagent (2005), 8 descendants of its own
- 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

## Indications for use
The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Source page: https://510kreport.com/device/K981931
Methodology: https://510kreport.com/methodology