# K053330: Architect B12 Calibrators

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Dec 16, 2005 after 15 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984108 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984108: Abbott Architect B12, Abbott Laboratories (1999) Summary page 1.

## Indications for use
The Abbott ARCHITECT B12 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma.

Source page: https://510kreport.com/device/K053330
Methodology: https://510kreport.com/methodology