# K051327: Abbott Axsym B12

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 3, 2005 after 75 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott ARCHITECT B12 assay: named in the summary without a submission number

## Indications for use
The AxSYM B12 reagent is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma on the AxSYM System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The AxSYM B 12 Specimen Diluent is used for manually diluting specimens for testing using the AxSYM B12 assay.

Source page: https://510kreport.com/device/K051327
Methodology: https://510kreport.com/methodology