# K974383: Elecsys Calcheck Vitamin B12

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 8, 1997 after 17 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 K924862 (1992). 2 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 13 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
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck (2006), 9 descendants of its own
- K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material (2014), 3 descendants of its own
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (2016), 2 descendants of its own
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator (2012), 1 descendant of its own
- K110579: Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls (2011), 1 descendant of its own

## Indications for use
Elecsys CalCheck Vitamin B12 calibration verification solutions comprise three levels - low, mid, and high - each with a defined Vitamin B12 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 Vitamin B12 is intended for use in periodic verification of the calibration of the Elecsys Vitamin B12 assay.

Source page: https://510kreport.com/device/K974383
Methodology: https://510kreport.com/methodology