# K032134: TSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: Sep 10, 2003 after 61 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.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083391: Thyroid Stimulating Immunoglobulin Reporter Assay (2009), 2 descendants of its own
- 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 TRab CT Assay Kit is for the quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum. The TRab CT Assay kit is iisehl as an aid in differential diagnosis of Graves’ disease.

Source page: https://510kreport.com/device/K032134
Methodology: https://510kreport.com/methodology