# K984163: Anti-Tpo Eia Diagnostic Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Feb 2, 1999 after 74 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This assay is intended for the in-vitro measurement of specific IgG antibodies against thyroid peroxidase (TPO) present in serum, as an aid in the diagnosis of autoimmune thyroid diseases.

Source page: https://510kreport.com/device/K984163
Methodology: https://510kreport.com/methodology