# K030912: Thyro Test

- Pathway: 510(k) (Traditional)
- Applicant: Thryotec
- Decided: Jul 25, 2003 after 123 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930007 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990658: Thyrochek One-Step Whole Blood Rapid TSH Assay, Little Nell Labs, Inc. (1999) Summary page 1.

## Recalls of this device
- Jan 24, 2007 · Not classified · Z-0646-2007: Positive control showed little or no positive line.

## Indications for use
The ThyroTest is a whole blood, qualitative assay for the detection of an increased level of TSH (Thyroid Stimulating Hormone). An increase level of TSH can be an indication of primary hypothyroidism. For Professional use only.

Source page: https://510kreport.com/device/K030912
Methodology: https://510kreport.com/methodology