Muscular Dystrophy Newborn Screening Test
The Muscular Dystrophy Newborn Screening Test is a Class 2 in vitro diagnostic device intended to measure creatine kinase levels from dried blood spot specimens obtained from newborns, used as an aid in screening for muscular dystrophy. It requires 510(k) clearance and is regulated under 21 CFR 862.1506 within the Clinical Chemistry medical specialty. The product code is QJE. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QJE
- Device Class
- FDA class 2
- Regulation Number
- 862.1506
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | Dec 12, 2019 | Unknown | Perkinelmer, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.