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510(k) Data Aggregation

    K Number
    K040008
    Device Name
    QUICKVUE ADVANCE PH AND AMINES GLL TEST
    Manufacturer
    QUIDEL CORP.
    Date Cleared
    2004-04-29

    (118 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K962718
    Why did this record match?
    Device Name :

    QUICKVUE ADVANCE PH AND AMINES GLL TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QuickVue Advance pH and Amines gll test contains two colorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH ≥ 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

    Device Description

    The QuickVue Advance pH and Amines gll test contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaqinal fluid pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the QuickVue® Advance pH and Amines gll test, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    pH Test:
    Differentiates vaginal fluid pH 4.7pH test produces a distinct greenish-blue plus sign against a yellow background and a greenish-blue procedural control dot for pH ≥ 4.7. For pH
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