LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962968

    Validate with FDA (Live)

    Device Name
    PROC APC ASSAY, PROC CONTROL PLASMA
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-12-13

    (136 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ProC APC is intended for the determination of the activated Protein C sensitivity of the activated partial thromboplastin time (aPTT) in citrated human plasma.

    Device Description

    The ProC APC assay consists of a liquid aPTT Reagent (containing phospholipids, silica-based activator), a lyophilized activated Protein C time (APCT) Reagent (containing activated human Protein C), and lyophilized Control Plasma (in the pathological range).

    AI/ML Overview

    This document describes the ProC APC assay, a device for determining activated Protein C sensitivity. However, this is a lab diagnostic test, not an AI/ML device, so it doesn't fit the requested format which pertains to AI/ML device studies. Factors like "sample size used for the test set and the data provenance," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," and "sample size for the training set" are not applicable to the description of this device.

    Therefore, I cannot fulfill the request in the specified format.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1