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510(k) Data Aggregation

    K Number
    K964294
    Device Name
    N-ASSAY TIA APO A1/B MULTI CALIBRATOR
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    N-ASSAY TIA APO A1/B MULTI CALIBRATOR

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

    The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, the information required to answer your request is not present. This document is an FDA 510(k) clearance letter for a medical device (N-Assay® A-1/B MULTI Calibrator Set), which primarily confirms substantial equivalence to a predicate device and outlines regulatory obligations.

    The document does not contain:

    • A table of acceptance criteria and reported device performance.
    • Details about a study proving the device meets acceptance criteria.
    • Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    These details are typically found in the 510(k) submission itself or in separate technical documentation and clinical study reports, which are not included in this clearance letter.

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