# K952183: Diastat Anti-Thyroglobulin Kit

- Pathway: 510(k) (Traditional)
- Applicant: Shield Diagnostics, Ltd.
- Decided: Jun 30, 1995 after 52 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: 1 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Apr 12, 2004 · Not classified · Z-0675-05: The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-T

Source page: https://510kreport.com/device/K952183
Methodology: https://510kreport.com/methodology