# K094031: Elecsys Folate Iii Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 27, 2010 after 118 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K010237 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092168: Elecsys HCG+B Calcheck 5, Roche Diagnostics (2009) Summary page 1.

## Indications for use
The Elecsys Folate III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K094031
Methodology: https://510kreport.com/methodology