# K100682: GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001U

- Pathway: 510(k) (Traditional)
- Applicant: Wallac OY
- Decided: Jul 23, 2010 after 135 days
- Product code: JLX (Radioimmunoassay, 17-Hydroxyprogesterone)
- Device class: 1
- Regulation: 21 CFR 862.1395
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912026 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081922: Autodelfia Neonatal 17A-OH-Progesterone Kit, Wallac OY (2009) Summary page 1.

## Indications for use
The GSP Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a,-OH-progesterone in blood-specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the GSPTM instrument.

Source page: https://510kreport.com/device/K100682
Methodology: https://510kreport.com/methodology