# K042425: Autodelfia Neonatal 17A-OH-Progesterone Kit

- Pathway: 510(k) (Special)
- Applicant: Wallac OY
- Decided: Sep 30, 2004 after 22 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: 1 generation back to K912026 (1991). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912026: Delfia (R) 17 -OH-Progesteron Kit, Pharmacia Diagnostics, Inc. (1991) Summary page 1.
- K935047: Auto Delfia, Wallac OY (1994) Summary page 1.

## Most influential descendants
- K081922: Autodelfia Neonatal 17A-OH-Progesterone Kit (2009), 1 descendant of its own
- K100682: GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001U (2010), 0 descendants of its own
- K060452: Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah (2007), 0 descendants of its own
- K050960: Modification to: Autodelfia Neonatal 17A-OH-Progesterone L Kit (2005), 0 descendants of its own

## Indications for use
This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.

Source page: https://510kreport.com/device/K042425
Methodology: https://510kreport.com/methodology