LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983127
    Device Name
    OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    1998-09-14

    (6 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3 are intended for use as a consistent tool for monitoring assay performance of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains a cover letter from the FDA regarding a 510(k) premarket notification for "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels 1 and 2". It also includes a "Statement of Indications for Use" for "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3".

    This document does not contain any information about:

    1. Acceptance criteria or reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth was established for the training set.

    Therefore, I cannot fulfill your request with the input provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1