# K110274: Autodelfia Neonatal Irt Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Decided: Jun 10, 2011 after 130 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: 1 (0 Class I)
- 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.

## Recalls of this device
- Sep 25, 2017 · Class III · Z-1220-2018: The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting

## Indications for use
The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

Source page: https://510kreport.com/device/K110274
Methodology: https://510kreport.com/methodology