BEUDAMED
    Product Code: PQU FDA class 2 21 CFR 862.1488

    Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

    Clinical Chemistry

    The Alpha-D-Glucosidase (GAA) Newborn Screening Test System is an in vitro diagnostic device for the quantitative measurement of alpha-D-glucosidase enzyme activity from newborn dried blood spot specimens, used in newborn screening to detect Pompe disease (glycogen storage disease type II). 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 PQU; not an implant and not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PQU
    Device Class
    FDA class 2
    Regulation Number
    862.1488
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For quantitative measurement of the activity of alpha-D-glucosidase (GAA) from newborn dried blood spot specimens.

    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.