# K121314: Architect B12

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 17, 2012 after 15 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: 5 generations back to K924862 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110579: Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls, Abbott Laboratories (2011) Summary page 2.

## Cited in the summary but kept off the family tree
- K093401: ARCHITECT B12 Calibrators. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Indications for use
The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B 12 in human serum and plasma 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 Calibrators are used to calibrate the ARCHITECT iSystem when the system is used for the quantitative determination of vitamin B 12 in human serum and plasma using the ARCHITECT B 12 Reagent Kit. 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 serm and plasma when using the ARCHITECT B12 Reagent Kit.

Source page: https://510kreport.com/device/K121314
Methodology: https://510kreport.com/methodology