# K112443: Architect Active B-12 (Holotranscobalamin)

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Dec 19, 2011 after 117 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: 3 generations back to K993571 (1999). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062467: Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10, Axis-Shield Diagnostics, Ltd. (2006) Summary page 2.

## Most influential descendants
- K160757: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (2016), 1 descendant of its own
- K233541: ARCHITECT Active-B12 (Holotranscobalamin) (2024), 0 descendants of its own
- K172133: ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (2017), 0 descendants of its own
- K121946: Axis-Shield Acvtive-B12 (2013), 0 descendants of its own

## 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. The ARCHITECT Active-B12 (Holotranscobalamin) Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of Holotranscobalamin in human serum. The ARCHITECT Active-B12 (Holotranscobalamin) Controls are for the estimation of test precision and the detection of. systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument) when used for the quantitative determination of Holotranscobalamin in human serum.

Source page: https://510kreport.com/device/K112443
Methodology: https://510kreport.com/methodology