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    K Number
    K141532
    Device Name
    CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2014-07-14

    (34 days)

    Product Code
    DKZ,DIO
    Regulation Number
    862.3100
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    k130665
    Why did this record match?
    Device Name :

    CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE

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

    CR3 Keyless Split Sample Cup Amphetamine-Cocaine is a rapid test for the qualitative detection of d-Amphetamine (major metabolite of Amphetamine) and Benzoylecgonine (major metabolite of Cocaine) in human urine at a cutoff concentration of 1000ng/mL and 300ng/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 Amphetamine-Cocaine test uses immunochromatographic assays for amphetamine and cocaine. The test is a lateral flow, one step system for the qualitative detection of d-Amphetamine (major metabolite of Amphetamine) and Benzoylecgonine (major metabolite of Cocaine) in human urine.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance for CR3 Keyless Split Sample Cup Amphetamine-Cocaine

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a formal table of "acceptance criteria" with specific thresholds for sensitivity, specificity, accuracy, etc., that the device must meet. Instead, the performance characteristics section describes the results of various studies, implying that these results are considered acceptable for demonstrating substantial equivalence.

    Here's a summary of the reported device performance for Amphetamine (AMP) and Cocaine (COC) testing, based on the precision, cut-off verification, and comparison studies:

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance (AMP)Reported Device Performance (COC)
    Precision (Cut-off)Consistent and expected results around the cut-off.For cut-off (1000 ng/mL), 42-43 out of 50 tests were positive across 3 lots (84-86% positive).For cut-off (300 ng/mL), 41-43 out of 50 tests were positive across 3 lots (82-86% positive).
    Precision (+25% Cut-off)All positive at +25% of cut-off.50/50 positive across 3 lots (100%).50/50 positive across 3 lots (100%).
    Precision (-25% Cut-off)All negative at -25% of cut-off.50/50 negative across 3 lots (100%).50/50 negative across 3 lots (100%).
    Cut-off VerificationAll positive at +25% and +50% cut-off; all negative at -25% and -50% cut-off.Pass: All positive at +25% & +50%; all negative at -25% & -50%.Pass: All positive at +25% & +50%; all negative at -25% & -50%.
    InterferenceNo interference from common substances at 100 ug/mL.Wide range of listed substances showed no interference.Wide range of listed substances showed no interference.
    Specificity (Cross-reactivity)Detailed cross-reactivity for related compounds with % values.d-Amphetamine: 100%, l-Amphetamine: 2%, d,l-Amphetamine: 33%, MDA: 20%, Phentermine: 33%, others
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