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    K Number
    K163101
    Device Name
    CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
    Manufacturer
    MICROGENICS CORPORATION
    Date Cleared
    2017-04-06

    (150 days)

    Product Code
    DJG,DLJ,LAS
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K040316
    Why did this record match?
    Device Name :

    CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA

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

    The CEDIA Buprenorphine II Assay is a homogeneous enzyme immunoassay for the qualitative and/or semiquantitative determination for the presence of buprenorphine and its metabolites in human urine at a cut-off concentration of 10 ng/ mL. The assay is intended to be used in laboratories and provides a simple and rapid analytical screening procedure to detect buprenorphine and its metabolites in human urine. The assay is designed for use with a number of clinical chemistry analyzers.

    The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid chromatography/tandem mass spectrometry (LC-MS/ MS) or permitting laboratories to establish quality control procedures.

    The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.

    Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

    CEDIA Buprenorphine II Calibrators:

    The CEDIA Buprenorphine II calibrators and CEDIA Negative Calibrator II are intended for the calibration of the CEDIA Buprenorphine II Assay in human urine. For In Vitro Diagnostic Use Only.

    CEDIA Buprenorphine II Control Set:

    The CEDIA Buprenorphine II controls are used to validate the CEDIA Buprenorphine II Assay calibration in human urine. For In Vitro Diagnostic Use Only.

    Device Description

    The assay consists of buffers (1 and 2) and lyophilized reagents (1a and 2a). The components include mouse monoclonal anti-buprenorphine antibody, recombinant microbial "enzyme donor'' - buprenorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives. Calibrators and controls are sold separately.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the CEDIA Buprenorphine II Assay, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance Criteria (Implicit/Explicit)Reported Device Performance (CEDIA Buprenorphine II Assay)
    Precision (Qualitative Mode)-100% to -25% spiked samples: 100% Negative-100% to -25% spiked samples: 100% Negative (80/80)
    +25% to +100% spiked samples: 100% Positive+25% to +100% spiked samples: 100% Positive (80/80)
    At 100% cutoff (10 ng/mL): Mix of Negative/Positive results expected around cutoffAt 100% cutoff (10 ng/mL): 27 Negative / 53 Positive (80 determinations)
    Precision (Semi-Quantitative Mode)-100% to -25% spiked samples: 100% Negative-100% to -25% spiked samples: 100% Negative (80/80)
    +25% to +100% spiked samples: 100% Positive+25% to +100% spiked samples: 100% Positive (80/80)
    At 100% cutoff (10 ng/mL): Mix of Negative/Positive results expected around cutoffAt 100% cutoff (10 ng/mL): 35 Negative / 45 Positive (80 determinations)
    Spike Recovery (Semi-Quantitative)Spiked 7.5 ng/mL sample: Negative100% (20/20) Negative
    Spiked 12.5 ng/mL sample: Positive100% (20/20) Positive
    Recovery within 80-120% of nominal valuesAchieved for spiked samples
    Analytical Recovery and Dilution Linearity(Implicit: Acceptable linearity and recovery across range for accurate quantification)Refer to table for specific levels; e.g., 5 ng/mL - 119.8%, 100 ng/mL - 104.7%
    Method Comparison and Accuracy (Qualitative)(Implicit: High agreement with LC-MS/MS, especially outside near-cutoff zones)High agreement in "Negative" (50% cutoff) categories. Discordant samples detailed.
    Method Comparison and Accuracy (Semi-Quantitative)(Implicit: High agreement with LC-MS/MS, especially outside near-cutoff zones)High agreement in "Negative" (50% cutoff) categories. Discordant samples detailed.
    Specificity (Cross-reactivity with Buprenorphine metabolites)(Implicit: Detect target analytes effectively)Buprenorphine, Norbuprenorphine, Norbuprenorphine-ß-D-glucuronide: ≥ 100% cross-reactivity. Buprenorphine-ß-D-glucuronide: 76.9% cross-reactivity.
    Specificity (Cross-reactivity with other compounds)(Implicit: Negligible cross-reactivity with structurally related/unrelated opiates and other commonly co-administered drugs)Negligible cross-reactivity (
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