# K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 19, 2009 after 308 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: 7 generations back to K931172 (1993). 19 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043318: Modification to Roche Elecsys Folate II Immunoassay, Roche Diagnostics Corp. (2004) Summary page 4.
- K051292: Elecsys RBC Folate Hemolyzed Reagent, Roche Diagnostics Corp. (2005) Summary page 4.
- K042490: Elecsys Folate II Calset II, Roche Diagnostics Corp. (2004) Summary page 4.
- K043320: Modification to Roche Elecsys Folate II Calcheck II, Roche Diagnostics Corp. (2004) Summary page 4.
- K051517: Elecsys Precicontrol Anemia, Roche Diagnostics Corp. (2005) Summary page 11.

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

## Indications for use
(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use. (2) Eleesys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. (3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers. (4) Elecsys Folate III Ca!Check: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys.Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers. (5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K082340
Methodology: https://510kreport.com/methodology