# K103484: GSP Neonatal Thyroxine (T4)

- Pathway: 510(k) (Traditional)
- Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Decided: Apr 22, 2011 after 147 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- 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 K943416 (1995). 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)
- K943416: Delfia Neonatal Thyroxine Kit, Wallac OY (1995) Summary page 1.

## Indications for use
The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.

Source page: https://510kreport.com/device/K103484
Methodology: https://510kreport.com/methodology