# K102419: GSP Neonatal Irt Kit (3306-001U)

- Pathway: 510(k) (Traditional)
- Applicant: Wallac Oy, Subsidiary of Perkinelmer
- Decided: Dec 16, 2010 after 113 days
- Product code: JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin)
- Device class: 1
- Regulation: 21 CFR 862.1725
- 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 K003668 (2001). 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)
- K003668: Autodelfia Neonatal Irt Kit, Model B005-112, Wallac OY (2001) Summary page 1.

## Indications for use
The GSP Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) in blood specimens (dried on filter paper) as an aid in screening newborns for Cystic Fibrosis using the GSP instrument.

Source page: https://510kreport.com/device/K102419
Methodology: https://510kreport.com/methodology