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510(k) Data Aggregation

    K Number
    K043556
    Device Name
    SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2005-03-28

    (91 days)

    Product Code
    JXM
    Regulation Number
    862.3170
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K023048
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BNZG reagent, when used in conjunction with SYNCHRON® System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine (BNZG) in human urine at a cutoff value of 200 ng/mL (oxazepam).

    Device Description

    The BNZG assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary analytical result, a positive result by these assays should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and supporting study for the SYNCHRON® Systems BNZG Reagent, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state 'acceptance criteria' in a formal table with predefined targets. However, the study aims to demonstrate substantial equivalence to a predicate device, and the concordance summary provides the key performance metrics. Based on common practice for this type of device, acceptable performance would typically involve high sensitivity, specificity, and overall agreement with a confirmatory method, as well as good imprecision.

    Here's a table based on the provided results, with implied acceptance based on the successful clearance of the device:

    MetricAcceptance Criteria (Implied)Reported Device Performance (SYNCHRON® Systems BNZG Reagent)
    Concordance Study
    SensitivityHigh agreement with GC/MS (e.g., >90%)98% (for both SYNCHRON CX and LX systems)
    SpecificityHigh agreement with GC/MS (e.g., >80%)84% (for both SYNCHRON CX and LX systems)
    Overall AgreementHigh agreement with GC/MS (e.g., >90%)92% (for both SYNCHRON CX and LX systems)
    Imprecision Study(Representative values shown)
    Within-Run %CVLow variability (e.g.,
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