# K033603: Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 19, 2003 after 32 days
- Product code: LIG (Radioassay, Intrinsic Factor Blocking Antibody)
- 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: 1 generation back to K811927 (1982). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811927: 1F Blocking Antibody (57 CO) Radioassay, Corning Medical & Scientific (1982) Summary page 1.

## Most influential descendants
- K240800: Access Intrinsic Factor Ab (2024), 0 descendants of its own

## Indications for use
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

Source page: https://510kreport.com/device/K033603
Methodology: https://510kreport.com/methodology