# K063437: Accubind Neo-TSH Microwell Elisa, Model 3425-300

- Pathway: 510(k) (Traditional)
- Applicant: Monobind, Inc.
- Decided: Apr 4, 2008 after 507 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 K772192 (1978). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K772192: Neonatal TSH Ria Kit (125I), Diagnostic Products Corp. (1978) Summary page 1.

## Indications for use
The Monobind AccuBind Neo-TSH Microwell Elisa Assay is an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper. It is intended to be used to screen newborns for congenital hypothyroidism.

Source page: https://510kreport.com/device/K063437
Methodology: https://510kreport.com/methodology