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510(k) Data Aggregation

    K Number
    K983697
    Date Cleared
    1998-12-11

    (51 days)

    Product Code
    Regulation Number
    862.3250
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

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

    Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse.

    Device Description

    Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse. The proposed Abuscreen ONLINE Cocaine Metabolite test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Abuscreen ONLINE® Cocaine Metabolite device:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in a separate section. However, by comparing the proposed device's performance to the predicate device, we can infer that the acceptance criteria for the new device align with demonstrating substantial equivalence to the predicate, particularly in the key performance characteristics. The table below summarizes the reported performance for the new device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's, considering the specified cutoff levels.

    Performance CharacteristicAcceptance Criteria (Implied, based on Predicate)Reported Device Performance (Proposed: Abuscreen ONLINE Cocaine for Hitachi 917)
    Precision Qualitative (300 ng/mL Cutoff):
    >95% negative at 225 ng/mL>95% negative at 240 ng/mL>95% negative at 225 ng/mL
    >95% positive at 375 ng/mL>95% positive at 360 ng/mLL>95% positive at 375 ng/mL
    Within Run Precision (Qualitative - OD):Similar CV% to predicate (not explicitly stated, but implied goal is low CV%)
    150 ng/mL (Mean OD, CV%)Not explicitly stated6245, 1.3 %
    225 ng/mL (Mean OD, CV%)Not explicitly stated4436, 1.0 %
    300 ng/mL (Mean OD, CV%)Not explicitly stated2746, 1.1 %
    375 ng/mL (Mean OD, CV%)Not explicitly stated1907, 1.4 %
    450 ng/mL (Mean OD, CV%)Not explicitly stated1708, 1.9 %
    Day-to-Day Precision (Qualitative - OD):Similar CV% to predicate
    150 ng/mL (Mean OD, CV%)Not explicitly stated6178, 1.7 %
    225 ng/mL (Mean OD, CV%)Not explicitly stated4379, 2.0 %
    300 ng/mL (Mean OD, CV%)Not explicitly stated2696, 2.4 %
    375 ng/mL (Mean OD, CV%)Not explicitly stated1873, 2.9 %
    450 ng/mL (Mean OD, CV%)Not explicitly stated1661, 2.5 %
    Precision Quantitative (300 ng/mL Cutoff):Similar CV% to predicate (e.g., 50 Pos., 0 Neg. (100% agreement)
    Limit of Detection (LoD):
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