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510(k) Data Aggregation

    K Number
    K972295
    Device Name
    SERAQUEST VZV IGG
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    1997-11-05

    (139 days)

    Product Code
    LFY
    Regulation Number
    866.3900
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERAQUEST VZV IGG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. For in vitro diagnostic use only.
      1. For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
      1. Individual specimens may be used for the determination of immune status.
    • Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
    • For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer the request as there is no information about the acceptance criteria and study that proves the device meets the acceptance criteria. The text consists of a letter from the FDA regarding the 510(k) premarket notification for the SeraQuest VAV IgG device and its indications for use. It does not contain any details about performance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

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