# K982307: Wallac Neonatal Leucine Test Kit Model NL-1000

- Pathway: 510(k) (Traditional)
- Applicant: Wallac, Inc.
- Decided: Feb 2, 1999 after 216 days
- Product code: JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine)
- Device class: 2
- Regulation: 21 CFR 862.1555
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This Leucine Test is for the quantitation of leucine, isoleucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease. It is intended for use by trained, qualified laboratory professionals.

Source page: https://510kreport.com/device/K982307
Methodology: https://510kreport.com/methodology