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510(k) Data Aggregation

    K Number
    K981312
    Device Name
    3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
    Manufacturer
    BAYER CORP.
    Date Cleared
    1998-06-05

    (56 days)

    Product Code
    JLW,JIS,JJX
    Regulation Number
    862.1690
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of

    Device Description

    Not Found

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

    Device: 3rd Generation TSH Method for the Bayer Immuno 1™ System

    Intended Use: To quantitatively measure thyroid stimulating hormone (TSH) in human serum or plasma with 3rd generation sensitivity on the Bayer Immuno 1 System, for use in the diagnosis of thyroid or pituitary disorders.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by the performance benchmarks set against legally marketed predicate devices (Bayer Immuno 1 TSH Assay, (Chiron) Ciba-Corning ACS™ TSH-3 Assay, and (Roche) Boehringer-Mannheim Elecsys® TSH Assay). The specific acceptance criterion for sensitivity is explicitly stated in the "Indications For Use" as `

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