# K023593: Seraquest Anti-Thyroid Peroxidase (Tpo)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Feb 6, 2003 after 104 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Pharmacia Varelisa TPO Antibodies: named in the summary without a submission number

## Indications for use
1. For the quantitative detection of IgG antibodies to thyroid peroxidase in human serum by enzyme immunoassay. 2. The SeraQuest Anti-thyroid peroxidase test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. 3. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K023593
Methodology: https://510kreport.com/methodology