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510(k) Data Aggregation

    K Number
    K983386
    Device Name
    BIOSTREP A-DIRECT STREP A ANTIGEN TEST
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1998-11-25

    (60 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioStrep® A is intended for use as an in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called BioStrep® A. While it confirms the device's substantial equivalence and outlines regulatory guidelines, it does not contain any information regarding specific acceptance criteria, study details, or performance metrics for the device. Therefore, I cannot generate the requested information based on the given input.

    The document states:

    • The device is a "BioStrep® A" intended for the "qualitative detection of group A streptococcal antigen directly from throat swab specimens."
    • It's for "in vitro diagnostic product" use in "physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection."
    • It refers to a "legally marketed predicate device" for substantial equivalence but does not provide details about that predicate's performance or the specific study comparing the BioStrep® A to it.

    To answer your request, I would need a document that describes the clinical performance study, including acceptance criteria (e.g., sensitivity, specificity thresholds), the results of that study, and details about the data collection and analysis.

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