# K960195: Thyrochek One-Step Rapid TSH Assay

- Pathway: 510(k) (Traditional)
- Applicant: Franklin Diagnostics, Inc.
- Decided: Apr 15, 1996 after 90 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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 K930007 (1993). 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)
- K930007: Immulite TSH Third Generation Control, Diagnostic Products Corp. (1993) Summary page 1.

## Most influential descendants
- K990658: Thyrochek One-Step Whole Blood Rapid TSH Assay (1999), 1 descendant of its own
- K030912: Thyro Test (2003), 0 descendants of its own

## Indications for use
This new immunometric assay device is a single-use Class Il medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 plu/mi.

Source page: https://510kreport.com/device/K960195
Methodology: https://510kreport.com/methodology