# K072458: Gbi TSH Neonatal Screening Kit

- Pathway: 510(k) (Traditional)
- Applicant: Golden Bridge International, Inc.
- Decided: Apr 10, 2008 after 223 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Accuwell Thyroid Stimulating Hormone (TSH) ELISA: named in the summary without a submission number

## Indications for use
The GBI TSH Neonatal Screening Kit is designed for the quantitative determination of Thyroid Stimulating Hormone (TSH) concentrations in neonatal blood samples that have been collected onto Whatman 903 specimen collection paper. The results are used to screen newborns for congenital hypothyroidism.

Source page: https://510kreport.com/device/K072458
Methodology: https://510kreport.com/methodology