# K240469: Access TPO Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 9, 2024 after 171 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950090 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061382: Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227, Beckman Coulter, Inc. (2006) Summary page 4.

## Indications for use
The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems. The detection of TPOAb is an aid in the diagnosis of thyroid autoimmune disorders.

Source page: https://510kreport.com/device/K240469
Methodology: https://510kreport.com/methodology