# K990658: Thyrochek One-Step Whole Blood Rapid TSH Assay

- Pathway: 510(k) (Traditional)
- Applicant: Little Nell Labs, Inc.
- Decided: Jun 2, 1999 after 93 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: 2 generations back to K930007 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853717: Allegro TM HS-TSH Immunoassay System, Nichols Institute Diagnostics (1985) Summary page 1.
- K930007: Immulite TSH Third Generation Control, Diagnostic Products Corp. (1993) Summary page 1.
- K960195: Thyrochek One-Step Rapid TSH Assay, Franklin Diagnostics, Inc. (1996) Summary page 1.

## Most influential descendants
- K030912: Thyro Test (2003), 0 descendants of its own

## Indications for use
The ThyroChek whole blood, rapid TSH assay is a visual, non-instrument, qualitative, solid-phase, lateral flow, two-site immunochromatographic assay for identifiying capillary or venous blood samples that contain TSH>5 microlU/ml. The test is intended for use as an in-vitro diagnostic device by medical professionals to screen for primary hypothryoidism. it is not indicated for use as a screening method for neonatal hypothyroidism.

Source page: https://510kreport.com/device/K990658
Methodology: https://510kreport.com/methodology