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    K Number
    K142044
    Device Name
    CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2014-08-25

    (28 days)

    Product Code
    LCM,LAF
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k130665
    Why did this record match?
    Device Name :

    CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE

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

    CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is a rapid test for the qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL. respectively.

    The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

    For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

    Device Description

    The CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine test uses immunochromatographic assays for phencyclidine and methylenedioxymethamphetamine. The test is a lateral flow, one step system for the qualitative detection of phencyclidine and methylenedioxymethamphetamine in human urine.

    AI/ML Overview

    The provided document describes the performance characteristics of the "CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine" device, a rapid test for the qualitative detection of Phencyclidine (PCP) and Methylenedioxymethamphetamine (MDMA) in human urine.

    Here's an analysis based on the given information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or overall agreement. However, it presents the results of several performance studies that demonstrate the device's capabilities, particularly around the established cut-off concentrations.

    For the purpose of this analysis, we can infer the "acceptance criteria" from the performance reported in the "Precision" and "Lay-user study" sections, generally looking for high agreement around non-cutoff concentrations and a predictable range of positive/negative results at the cutoff.

    Implied Acceptance Criteria and Reported Performance:

    Study Type / MetricAcceptance Criteria (Inferred from common practice for drug tests)Reported Device Performance (PCP)Reported Device Performance (MDMA)
    Precision Study
    -100% Cut-off100% Negative50/0+ (50 Negative, 0 Positive) across 3 lots50/0+ (50 Negative, 0 Positive) across 3 lots
    -75% Cut-off100% Negative50/0+ across 3 lots50/0+ across 3 lots
    -50% Cut-off100% Negative50/0+ across 3 lots50/0+ across 3 lots
    -25% Cut-off100% Negative (or very high percentage negative)50/0+ across 3 lots50/0+ across 3 lots
    At Cut-off (25 ng/mL for PCP, 500 ng/mL for MDMA)Expected to show a mix of positive and negative results, demonstrating sensitivity at the cutoff, but no specific ratio is typically set as an acceptance criterion; rather, it should demonstrate the cutoff is truly a discrimination point.42+/8- (Lot 1 & 2), 43+/7- (Lot 3) for 50 tests42+/8- (Lot 1), 43+/7- (Lot 2 & 3) for 50 tests
    +25% Cut-off100% Positive (or very high percentage positive)50+/0- across 3 lots50+/0- across 3 lots
    +50% Cut-off100% Positive50+/0- across 3 lots50+/0- across 3 lots
    +75% Cut-off100% Positive50+/0- across 3 lots50+/0- across 3 lots
    +100% Cut-off100% Positive50+/0- across 3 lots50+/0- across 3 lots
    Lay-User Study
    Drug-free (-100%)100% Agreement with GC/MS (Negative)100%Not applicable (combined drug-free for both)
    -75% Cut-off100% Agreement with GC/MS (Negative)100%100%
    -50% Cut-off100% Agreement with GC/MS (Negative)100%100%
    -25% Cut-offHigh Agreement with GC/MS (Negative), ideally >95%85%90%
    +25% Cut-offHigh Agreement with GC/MS (Positive), ideally >95%85%
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