# K984108: Abbott Architect B12

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 3, 1999 after 78 days
- Product code: LIG (Radioassay, Intrinsic Factor Blocking Antibody)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AXSYM® B12 Assay: named in the summary without a submission number

## Most influential descendants
- K053330: Architect B12 Calibrators (2005), 0 descendants of its own

## Recalls of this device
- Mar 8, 2006 · Not classified · Z-0860-06: The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored on
- Aug 19, 2004 · Not classified · Z-1452-04: Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sampl
- Dec 14, 2001 · Not classified · Z-0435-05: Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.

## Indications for use
The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Source page: https://510kreport.com/device/K984108
Methodology: https://510kreport.com/methodology