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510(k) Data Aggregation

    K Number
    K964068
    Device Name
    CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
    Manufacturer
    BAYER CORP.
    Date Cleared
    1996-12-13

    (64 days)

    Product Code
    KLT
    Regulation Number
    862.3645
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This in viro method is intended to quantitatively measure carbemant drug, in human serum or plasma (heparin) using Syva EMIT 2000 Assay on a Technicon Immuno-1 system. Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.

    Device Description

    Not Found

    AI/ML Overview

    Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

    Acceptance Criteria and Device Performance Study

    The provided document describes the "Carbamazepine Method for Bayer Technicon Immuno 1 System" and its comparison to a predicate device, the "Syva EMIT® 2000 Carbanazepine Assay."

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" but presents performance metrics for both the Immuno 1 Carbamazepine method and the predicate device, implying these are the performance characteristics against which the new device is being evaluated for substantial equivalence.

    Performance MetricAcceptance Criteria (Implied by Predicate Device Performance)Immuno 1 Carbamazepine (Reported Device Performance)
    Minimum Detectable Conc.
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