# K043320: Modification to Roche Elecsys Folate II Calcheck II

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 17, 2004 after 15 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: 3 generations back to K924862 (1992). 3 ancestors in all.
8 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)
- K974384: Elecsys Calcheck Folate, Boehringer Mannheim Corp. (1997) 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
For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Source page: https://510kreport.com/device/K043320
Methodology: https://510kreport.com/methodology