# K021541: Neogram Pku Tandem Mass Spectrometry Kit

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer Life Sciences
- Decided: Oct 28, 2002 after 171 days
- Product code: JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine)
- Device class: 2
- Regulation: 21 CFR 862.1555
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Isolab Phenylalanine Test Kit: named in the summary without a submission number

## Recalls of this device
- Nov 26, 2012 · Class II · Z-0686-2013: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

## Indications for use
The kit is intended for screening for phenylketonuria (PKU). It involves the quantitative determination of phenylalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.

Source page: https://510kreport.com/device/K021541
Methodology: https://510kreport.com/methodology