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510(k) Data Aggregation

    K Number
    K955677
    Device Name
    SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1996-04-03

    (110 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K940158,K943998,K944701
    Why did this record match?
    Reference Devices :

    K940158, K943998, K944701

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON® CX4, CX@4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

    Device Description

    The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.

    AI/ML Overview

    Acceptance Criteria and Device Performance for BECKMAN SYNCHRON® Systems Cannabinoid 20 ng Reagent

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "equivalence" to a predicate device through various performance studies. Therefore, the "acceptance criteria" are inferred from the demonstrated performance that supports substantial equivalence.

    Performance MetricInferred Acceptance Criteria (based on predicate equivalence)Reported Device Performance (SYNCHRON Cannabinoid 20 ng Reagent)
    Overall AgreementHigh agreement with predicate (Emit II Cannabinoid Reagent)99%
    Relative SensitivityHigh sensitivity relative to predicate99%
    Relative SpecificityHigh specificity relative to predicate100%
    Number of Discordant with Emit IILow number of discordant results (indicating strong agreement)1
    Shelf-life (unopened)At least 12 months (matching or exceeding predicate)12 months
    On-Instrument StabilityAt least 60 days (matching or exceeding predicate)60 days
    Calibration Frequency7 days7 days
    Within-Run Imprecision (%CV)Low variability (e.g.,
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