# DEN180056: GSP Neonatal Creatine Kinase - MM kit

- Pathway: De Novo (Direct)
- Applicant: Perkinelmer, Inc.
- Decided: Dec 12, 2019 after 427 days
- Product code: QJE (Muscular Dystrophy Newborn Screening Test)
- Device class: 2
- Regulation: 21 CFR 862.1506
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The GSP Neonatal Creatine Kinase-MM kit, is intended for the quantitative in vitro determination of creatine kinase MM-isoform (CK-MM) concentration in blood specimens dried on filter paper as an aid in screening newborns for Duchenne Muscular Dystrophy (DMD) using the GSP instrument.

Source page: https://510kreport.com/device/DEN180056
Methodology: https://510kreport.com/methodology