# K020687: Diastat Anti-Thyroid Peroxidase Elisa Model #300

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: May 2, 2002 after 59 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
The Diastat™ Anti-Thyroid Peroxidase (anti-TPO) test is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection the IgG class of autoantibodies specific for thyroid peroxidase in human serum or EDTA, heparin or citrated plasma. It is intended to aid in the diagnosis of autoimmune thyroid disorders and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.

Source page: https://510kreport.com/device/K020687
Methodology: https://510kreport.com/methodology