# K110579: Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 6, 2011 after 219 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 K924862 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck, Roche Diagnostics Corp. (2006) Summary page 2.

## Most influential descendants
- K121314: Architect B12 (2012), 0 descendants of its own

## Indications for use
The ARCHITECT B12 assay is a chemi luminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The ARCHITECT B 12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum when using the ARCHITECT B12 Reagent Kit. The ARCHITECT B 12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum using the ARCHITECT B 12 Reagent Kit.

Source page: https://510kreport.com/device/K110579
Methodology: https://510kreport.com/methodology