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510(k) Data Aggregation

    K Number
    K012484
    Manufacturer
    Date Cleared
    2001-11-30

    (120 days)

    Product Code
    Regulation Number
    862.3100
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE

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

    The Ameditech ImmuTest™ Drug Screen AMPHETAMINE is an In Vitro Diagnostic test for the qualitative detection of Amphetamine in human urine at cut-off concentration of 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for the Ameditech ImmuTest™ Drug Screen Amphetamine, an in-vitro diagnostic device.
    However, the document does NOT contain the detailed study information required to answer the prompt.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for the test set or their provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication method for the test set.
    • Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Information on a standalone performance study.
    • Description of the type of ground truth used (e.g., pathology, expert consensus).
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This document is merely the FDA's clearance stating that the device is substantially equivalent to a legally marketed predicate device. The actual study data and results would be found in the 510(k) submission itself, which is not provided here.

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