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510(k) Data Aggregation

    K Number
    K022021
    Device Name
    VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
    Manufacturer
    VITAL SCIENTIFIC N.V.
    Date Cleared
    2002-11-01

    (134 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K884863,K881367,K891337
    Why did this record match?
    Device Name :

    VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT

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

    The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

    Device Description

    The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Vital Scientific APTT device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implied)Reported Vital Scientific APTT Performance
    Correlation with Predicate Device (APTT-LS on MLA 900C)"acceptable correlation" (implied by K891337)Correlation coefficient = 0.938, Slope = 0.727, Intercept = 6.96. The document states this indicates "acceptable correlation."
    Correlation with Predicate Device (APTT-LS on ACL-100)"acceptable correlation" (implied by K881367)Correlation coefficient = 0.930, Slope = 0.952, Intercept = 3.76. The document states this indicates "acceptable correlation."
    Within-run Precision (%CV)"
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