LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K050817
    Device Name
    T-TEK
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2005-12-12

    (256 days)

    Product Code
    GJA
    Regulation Number
    864.7875
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K884384
    Why did this record match?
    510k Summary Text (Full-text Search) :

    |
    | Classification Name: | Test, thrombin time
    (per 21 CFR section 864.7875
    Lafayette Blvd South Bend, IN 46601

    K050817 Re: Trade/Device Name: T-Tek Regulation Number: 21 CFR 864.7875

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

    The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

    Device Description

    The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study proving device performance for the R2 Diagnostics T-Tek, based on the provided 510(k) premarket notification:

    Note: This submission is for a medical reagent (thrombin time test) which typically focuses on chemical and functional equivalence to a predicate device, rather than the complex clinical performance metrics often seen with imaging AI devices. Therefore, some of the requested categories (e.g., MRMC studies, ground truth for training) are not directly applicable or explicitly detailed in this type of submission.

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    CorrelationCorrelation coefficient ($r^2$) for abnormal patient plasma (photo-optical instrument)$r^2 = 0.801$
    Slope (photo-optical instrument)$0.848$
    Intercept (photo-optical instrument)$3.466$
    Correlation coefficient ($r^2$) for abnormal patient plasma (mechanical instrument)$r^2 = 0.800$
    Slope (mechanical instrument)$1.204$
    Intercept (mechanical instrument)$-4.904$
    Precision (Within-run)Coefficient of Variation (CV)$
    Ask a Question

    Ask a specific question about this device

    K Number
    K970645
    Device Name
    BC THROMBIN REAGENT
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1997-05-19

    (88 days)

    Product Code
    GJA
    Regulation Number
    864.7875
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Thrombin Reagent is a Class II device and has a classification name of thrombin time test (21 CFR §864.7875

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

    The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:

    • The monitoring of heparin therapy.
    • The monitoring of fibrinolysis therapy.
    • The screening of disorders of fibrin formation.
    • The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
    Device Description

    The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).

    AI/ML Overview

    The provided document is a 510(k) summary for the BC Thrombin Reagent. This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive acceptance criteria and a standalone study for novel device performance. However, I can extract the relevant information from the "Comparative Analysis" and "Precision" sections to address your request as much as possible within the context of this submission.

    Here's an analysis based on the provided text:

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria TypeAcceptance Criteria (Implicit from predicate comparison)Reported Device Performance (BC Thrombin Reagent vs. Predicate)
    CorrelationHigh correlation with predicate deviceCorrelation coefficient: 0.93
    Agreement (Slope)Slope close to 1.0 (indicating proportional agreement)Slope: 1.48
    Agreement (Y-intercept)Y-intercept close to 0 (indicating absence of systematic bias)Y-intercept: -5.5
    Precision (Within-run)Low variability (e.g.,
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1