# K240800: Access Intrinsic Factor Ab

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 3, 2024 after 39 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: 2 generations back to K811927 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033603: Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999, Beckman Coulter, Inc. (2003) Summary page 4.

## 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/K240800
Methodology: https://510kreport.com/methodology