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510(k) Data Aggregation

    K Number
    K964015
    Device Name
    INDICARD TEST
    Manufacturer
    LITMUS CONCEPTS, INC.
    Date Cleared
    1997-06-19

    (255 days)

    Product Code
    MJM
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LITMUS CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis. The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.
    Device Description
    The Indicard™ test is an enzyme activity test.
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    K Number
    K962718
    Device Name
    FEMEXAM TESTCARD
    Manufacturer
    LITMUS CONCEPTS, INC.
    Date Cleared
    1997-02-07

    (210 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LITMUS CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.
    Device Description
    The FemExam® TestCard™ contains two qualitative, colorimetric tests: a pH test and an amine test. The pH test uses nitrazine yellow to produce a visual color change within two minutes of specimen application, indicating pH less than or greater than 4.7. It includes a positive procedural control and a negative background control. The amine test uses bromocresol green (BCG) and sodium aluminate to produce a visual color change within two minutes of specimen application, indicating the presence of alkali volatilizable amines. It also includes a positive procedural control and a negative background control.
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