# K971177: Immulite Vitamin B12 (LKVB1,LKVB5)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 16, 1997 after 46 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860815 (1986). 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)
- K860815: Solid Phase Boil Dualcount (Dualcount SPB), Diagnostic Products Corp. (1986) Summary page 1.
- K933315: Radias B12 Enzyme Immunoassay, Bio-Rad (1993) Summary page 1.

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1686-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

## Indications for use
IMMULITE® Vitamin B12 is a chemiluminescent assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative detection of vitamin B12 in human serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in clinical diagnosis and treatment of anemia.

Source page: https://510kreport.com/device/K971177
Methodology: https://510kreport.com/methodology