# K233541: ARCHITECT Active-B12 (Holotranscobalamin)

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Jul 31, 2024 after 271 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: 4 generations back to K993571 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112443: Architect Active B-12 (Holotranscobalamin), Axis-Shield Diagnostics, Ltd. (2011) Summary page 5.

## Indications for use
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency

Source page: https://510kreport.com/device/K233541
Methodology: https://510kreport.com/methodology