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510(k) Data Aggregation

    K Number
    K090191
    Device Name
    HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
    Manufacturer
    HANDYLAB, INC
    Date Cleared
    2010-05-27

    (485 days)

    Product Code
    NJR, OOI
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANDYLAB, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (>)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX GBS Assay can be used as an aid in determining colonization status in antepartum women. The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are necessary for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.
    Device Description
    The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (>)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX GBS Assay can be used as an aid in determining colonization status in antepartum women. The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are necessary for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.
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