Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K212183
    Device Name
    STA R Max 3, STA Compact Max 3
    Manufacturer
    Diagnostica Stago SAS
    Date Cleared
    2023-06-07

    (694 days)

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

    Diagnostica Stago SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
    Device Description
    The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles: Chronometric measurement principle and Photometry measurement principle. The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available reagents. The instrument performs multiple test methodologies in random access, as selected by the user. These include clotting time or clot-based tests (i.e. chronometric measures) and photometric assays on plasma samples. Changes include a redesigned PSR module to replace the Hamilton syringes and Valcor pump of the fluidic circuit and the addition of the HIL module for estimating interferences (Hemoglobin, Icterus, Lipemia).
    Ask a Question
    K Number
    K211485
    Device Name
    STA- NeoPTimal
    Manufacturer
    Diagnostica Stago SAS
    Date Cleared
    2022-12-23

    (589 days)

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

    Diagnostica Stago SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STA- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R family, STA Compact family and STA Satellite family instruments. STA- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).
    Device Description
    The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains: STA® - NeoPTimal 5: 6 x 5 ml vials of Reagent 1, 6 x 5 ml vials of Reagent 2 STA® - NeoPTimal 10: 12 x 10 ml vials of Reagent 1, 12 x 10 ml vials of Reagent 2 Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen. Reagent 2 is a solvent containing calcium. The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen). The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used: INR = ( Patient's PT / Mean Normal PT ) * ISI The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.
    Ask a Question

    Page 1 of 1