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    K Number
    K000462
    Device Name
    URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2000-04-06

    (55 days)

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

    URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

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

    The PCP Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.

    Device Description

    The Urine Phencyclidine (PCP) Screen Flex® reagent cartridge is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of phencyclidine in human urine.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Dade Behring Urine Phencyclidine (PCP) Screen Flex® reagent cartridge, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds. However, we can infer the performance metrics evaluated and their reported outcomes:

    Performance MetricImplied Acceptance Criteria (Inferred)Reported Device Performance
    Qualitative Analysis (Agreement with Predicate)High percentage agreement with the predicate device (Abbott AxSYM® System Phencyclidine II Assay) at the 25 ng/mL cutoff.98% agreement with the predicate method.
    Qualitative Analysis (Agreement with GC/MS for Discordant Samples)Discordant samples should have GC/MS values that explain the discrepancy.5 discordant samples (positive by PCP method, negative by AxSYM) had GC/MS values of 24, 20, 25, 19, 44 ng/mL.
    Qualitative Spiked Sample Recovery (Negatives)Samples spiked at = 25% of the cutoff (31.25-1000 ng/mL) should be consistently positive.Consistently distinguished as positive.
    Semiquantitative Spiked Sample RecoveryQuantitated values should be within 10% of the nominal concentration.Quantitated within 10% of the nominal concentration between 8 and 75 ng/mL.
    Semiquantitative Precision (Within-run %CV)Acceptable within-run precision for controls and cutoff concentrations. Specific threshold not given, but industry standards for immunoassays typically aim for low CVs (e.g.,
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