LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K965110
    Device Name
    N-ASSAY TIA MULTI CRP CALIBRATOR SET
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-03

    (195 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The N-Assay TIA Multi CRP CAlibrator Set is intended to be used in the calibration of the Crestat Diagnostics N-Assay TIAGRP turbidimmunometric assay for quantitating serum levels of C-Reactive Protein. in human serum.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter (K965110/S001 for N-Assay® TIA MULTI C-Reactive Protein Calibrator Set) does not contain the information required to answer your request.

    The letter is a notification of substantial equivalence for a medical device (a calibrator set for an assay). It outlines regulatory compliance and allows the device to be marketed. However, it does not describe:

    • Acceptance criteria for device performance.
    • A study proving the device meets acceptance criteria (including all the specified details like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.).

    This type of information would typically be found in the 510(k) submission document itself, which is not provided, or a separate study report. The letter is a regulatory approval, not a scientific study summary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1