# K973702: Elecsys Vitamin B12 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 13, 1997 after 48 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935286 (1994). 1 ancestor in all.
10 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)
- K935286: Quantaphase II B12/Folate, Bio-Rad (1994) 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
A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained with this device are used in the diagnosis and treatment of

Source page: https://510kreport.com/device/K973702
Methodology: https://510kreport.com/methodology