Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
The Alpha-D-Galactosidase A (GLA) Newborn Screening Test System is an in vitro diagnostic device for the quantitative measurement of alpha-D-galactosidase A enzyme activity from newborn dried blood spot specimens, used in newborn screening to detect Fabry disease. It is classified as FDA Class 2 under 21 CFR 862.1488 in the Clinical Chemistry specialty, requiring 510(k) clearance, and is eligible for third-party review. Product code PQW; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQW
- Device Class
- FDA class 2
- Regulation Number
- 862.1488
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.