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510(k) Data Aggregation

    K Number
    K014008
    Device Name
    HEMOCHRON JR. CITRATE APTT CUVETTE
    Manufacturer
    ITC, INC.
    Date Cleared
    2002-01-24

    (50 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings. For In Vitro Diagnostic Use Only
    Device Description
    The Hemochron Jr.Citrate APTT test is a self-contained disposable test cuvette, pre-filled with dried reagents required to perform an Activated Partial Thromboplastin Time (APTT) using citrated whole blood in the Hemochron Jr. Whole Blood Microcoagulation Analyzers. The preparation consists of kaolin, phospholipid, stabilizers and buffers. These same components are used in the previous formulation of the citrate APTT. The citrate APTT test can be performed on both the Hemochron Jr. II and Hemochron Jr. Signature Series instruments. The test is intended for point of care use. The instrument draws a precise volume of blood into the test channel of the cuvette. The cuvette contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision channel. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.
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