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510(k) Data Aggregation

    K Number
    K102851
    Device Name
    NOFACT VIII
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2011-12-19

    (446 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
    Device Description
    NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
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    K Number
    K102908
    Device Name
    NOFACT IX
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2011-12-19

    (444 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
    Device Description
    NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplast time. For in vitro diagnostic use.
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    K Number
    K090105
    Device Name
    LUPOTEK KCT
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2010-12-30

    (714 days)

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

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083878
    Device Name
    LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2010-06-25

    (543 days)

    Product Code
    GIR, GGC
    Regulation Number
    864.8950
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LupoTek Detectin VL and Correctin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories. PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.
    Device Description
    LupoTek Detectin VL and LupoTek Correctin VL use Vipera lebetina venom rather than Vipera russelli (Russell's Viper) venom in the dRVVT assay for lupus anticoagulant. Vipera lebetina venom, like Russell's viper venom, will directly activate Factor X without requiring Factor VII. The activated Factor X in conjunction with Factors V, II, calcium ions and phospholipid will generate thrombin which converts fibrinogen to fibrin, producing a clot in the test system. LupoTek Detectin VL, the low phospholipid reagent, is designed as the screening reagent to detect a prolongation of the clotting time. LupoTek Correctin VL is the high phospholipid reagent that neutralizes the LA and corrects the clotting time to normal, confirming the presence of a Lupus Anticoagulant. PlasmaCon LA is a lyophilized Lupus Anticoagulant (LA) positive plasma suitable for use as a quality control plasma for in vitro diagnostic assays in the clinical coagulation laboratory sensitive for the presence of LA
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    K Number
    K082631
    Device Name
    THROMBO TEK PSE, MODEL 90-480
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2008-12-17

    (98 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThromboTek PSe is intended for the quantitative determination of functional Protein S activity in human plasma. ThromboTek PSe is intended for the quantitative determination of functional Protein S activity, such as when identifying inherited or acquired Protein S deficiency.
    Device Description
    ThromboTek PSe is a tissue factor pathway based clotting assay. The assay activator is a lyophilized preparation incorporating rabbit thromboplastin, calcium, buffer, and stabilizers. The remaining components of the assay are lyophilized activated Protein C, lyophilized human plasma depleted of Protein S, Imidazole buffered saline for use as a plasma diluent, and deionized water containing a preservative for reconstitution of the lyophilized components.
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    K Number
    K062306
    Device Name
    PLASMACON N, PLASMACON L-1, PLASMACON L-2
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2007-03-16

    (220 days)

    Product Code
    GGC, GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests. PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests. PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
    Device Description
    The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K042919
    Device Name
    FIBROTEK FIB
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2004-11-29

    (38 days)

    Product Code
    GIS, KQJ
    Regulation Number
    864.7340
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
    Device Description
    FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma.
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    K Number
    K040296
    Device Name
    PHOSPHOPLASTIN RL
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2004-05-24

    (105 days)

    Product Code
    GJS
    Regulation Number
    864.7750
    Why did this record match?
    Applicant Name (Manufacturer) :

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phosphoplastin RL Prothrombin Time reagent is a liquid PT reagent containing thromboplastin derived from rabbit brain and calcium ions for use in the determination of Prothrombin Time (PT) and related coagulation procedures. The PT test is a one-stage test used in routine patient screening for disorders in the extrinsic pathway of coagulation and for monitoring patients undergoing Oral Anti-Coagulant (OAC) therapy. Phosphoplastin RL should only be used in an appropriate clinical laboratory by qualified laboratory personnel and is provided ready-to-use.
    Device Description
    Phosphoplastin RL PT reagent is a liquid, ready-to-use reagent containing thromboplastin derived from rabbit brain, calcium ions, buffers, stabilizers and preservatives. Phosphoplastin RL is intended for use in a one-stage prothrombin time (PT) test on citrated human plasma.
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    K Number
    K033471
    Device Name
    PHOSPHOLIN ES AND CALCIUM CHLORIDE
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2004-02-04

    (93 days)

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

    R2 DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.
    Device Description
    R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.
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