# K993697: Delfia Neonatal Irt Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wallac OY
- Decided: Jun 9, 2000 after 220 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- 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 K791202 (1979). 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)
- K791202: Ria Kit for Trypsin, Cis Radiopharmaceuticals, Inc. (1979) Summary page 1.

## Indications for use
This kit is intended for the quantitative determination of immunoreactive trypsin (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis.

Source page: https://510kreport.com/device/K993697
Methodology: https://510kreport.com/methodology