# K083391: Thyroid Stimulating Immunoglobulin Reporter Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: May 21, 2009 after 185 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: 1 generation back to K032134 (2003). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032134: TSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit, Kronus Market Development Associates, Inc. (2003) Summary page 3.

## Most influential descendants
- K092229: Thyretain TM Tsi Reporter Bioassay (2010), 1 descendant of its own
- K152061: IMMULITE 2000 TSI Assay,  IMMULITE 2000 TSI Calibration Verification Material (2016), 0 descendants of its own

## Indications for use
The Thyretain TM TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).

Source page: https://510kreport.com/device/K083391
Methodology: https://510kreport.com/methodology