# K974384: Elecsys Calcheck Folate

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 8, 1997 after 17 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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 K924862 (1992). 2 ancestors in all.
9 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)
- K963147: Elecsys Calcheck TSH, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K043320: Modification to Roche Elecsys Folate II Calcheck II (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
- K103716: Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset (2011), 1 descendant of its own

## Indications for use
Elecsys CalCheck Folate calibration verification solutions comprise three levels - low, mid, and high - each with a defined Folate concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys CalCheck Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.

Source page: https://510kreport.com/device/K974384
Methodology: https://510kreport.com/methodology