# K973674: Elecsys Folate

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 12, 1997 after 47 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- 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.
10 later devices descend from it; 1 cites it directly.
0 of 12 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
- K031756: Roche Diagnostics Elecsys Folate II Assay (2003), 9 descendants of its own
- K043318: Modification to Roche Elecsys Folate II Immunoassay (2004), 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

## Indications for use
Assay for the in vitro quantitative determination of folate in human serum. The electrochemiluminescence assay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys assay analyzers.

Source page: https://510kreport.com/device/K973674
Methodology: https://510kreport.com/methodology