Search Filters

Search Results

Found 15 results

510(k) Data Aggregation

    K Number
    K102552
    Device Name
    HEMOSIL LA POSITIVE CONTROL
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2011-04-05

    (210 days)

    Product Code
    GGC, GGN, GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - HemosIL LA Positive Control . For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays. - . HemosIL LA Negative Control For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
    Device Description
    - . HemosIL LA Positive Control The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1. The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays. - HemosIL LA Negative Control The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA). The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
    Ask a Question
    K Number
    K100103
    Device Name
    SPECIALTY ASSAYED CONTROL-2
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2010-12-15

    (336 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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?
    Product Code :

    GGC

    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.
    Ask a Question
    K Number
    K061803
    Device Name
    STA - CONTROL LA 1+2
    Manufacturer
    DIAGNOSTICA STAGO, INC.
    Date Cleared
    2006-07-28

    (31 days)

    Product Code
    GGC, GGN
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests: STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
    Device Description
    The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
    Ask a Question
    K Number
    K032804
    Device Name
    CRYOCHECK WEAK LUPUS POSITIVE CONTROL
    Manufacturer
    PRECISION BIOLOGIC
    Date Cleared
    2003-11-03

    (55 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
    Device Description
    CryoCheck Weak Lupus Positive Control contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants. Source plasmas are processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, aliquoted and rapidly frozen.
    Ask a Question
    K Number
    K023312
    Device Name
    CONTROL PLASMA P
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2002-11-01

    (29 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Fibrinogen (Clauss method); Coagulation factors II, V, VII, VIII, VWf, IX, X, XI, XII and XIII*; Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C, inhibitor*; Total complement activity*, Plasminogen. (* Not available in the U.S.)
    Device Description
    Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological ranqe.
    Ask a Question
    K Number
    K020878
    Device Name
    LYPHOCHEK HEMOSTASIS, MODELS 798, 799
    Manufacturer
    BIO-RAD
    Date Cleared
    2002-04-15

    (28 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
    Ask a Question
    K Number
    K020109
    Device Name
    SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2002-02-06

    (26 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
    Device Description
    Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.
    Ask a Question
    K Number
    K012422
    Device Name
    K-ASSAY D-DIMER CONTROLS
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2001-08-21

    (22 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.
    Device Description
    Not Found
    Ask a Question
    K Number
    K003329
    Device Name
    SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-03-01

    (128 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Product Code :

    GGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 2