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510(k) Data Aggregation

    K Number
    K082661
    Device Name
    BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    2008-10-06

    (24 days)

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

    The StatusFirst™ Strep 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

    This document is a 510(k) clearance letter for three different Strep A rapid diagnostic tests: StatusFirst™ Strep A, BioStrep® A, and BioSign® Strep A / Status AccuStrepA™. However, it does not contain the detailed study information regarding acceptance criteria and performance data. The letter only states that the devices are substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance for the device, not the technical performance study details.

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