# K974047: Accuwell Phenylalanine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Neometrics, Inc.
- Decided: Dec 5, 1997 after 42 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
Neometricss ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboms for PKU (phenylketonuria) disease.

Source page: https://510kreport.com/device/K974047
Methodology: https://510kreport.com/methodology