Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K161329
    Device Name
    Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
    Manufacturer
    Chrono-log Corp.
    Date Cleared
    2016-12-02

    (204 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chrono-log Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chrono-log Model 490 4+4 Aggregometer is intended for use for in-vitro diagnostic use for measuring Platelet Aggregation in Platelet Rich Plasma. This device is intended to be used in a clinical laboratory environment by laboratory technicians. For use only with light transmission aggregometry assays cleared for use with the Chrono-log Platelet Aggregometry systems.
    Device Description
    The Chrono-log™ Model 490 4+4 Aggregometer measures platelet function on patient samples using LTA which measures a change in optical density of platelet rich plasma. The Model 490 4+4 is also used to run the Ristocetin Cofactor Assay to aid in diagnosis of patients with von Willebrand disease. The instrument comes with a starter kit of reagents and supplies. The output of the Model 490 4+4 can be connected to either a strip chart recorder or to a Computer. Software is provided with the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 490 4+4 Aggregometer. LTA or Born method of platelet aggregation measures the change in optical density of a Platelet Rich Plasma (PRP) sample in comparison to optical density of a Platelet Poor Plasma (PPP) sample. The PRP sample, platelets in a suspension of plasma, is isolated from an anticoagulated blood sample by a relatively low centrifugation. The PPP sample is prepared by centrifuging the blood sample at a relatively high force. The Chrono-log sample chambers are designed so that a beam of infra red light shines through two cuvettes. one containing PRP (the sample) and one containing PPP (the reference). Silicon photodiodes detect the light able to pass through the samples: PRP is arbitrarily considered to be 0% light transmission or 0% aggregation: PPP is considered to be 100% light transmission or 100% aggregation. When a stimulus is added to the cuvette containing PRP and the platelets respond forming aggregates, more light is allowed to pass through the PRP sample. The change in light transmission, recorded over time, shows a trend towards the platelet poor plasma, or 100% light transmission. A graphical tracing of the change in optical density during the course of platelet aggregation is produced either on a strip chart recorder or on a computer using Chrono-log provided software. This device is designed to be used in the clinical laboratory as an in vitro diagnostic tool. The 490 4+4 varies from the predicate devices only in the number of channels.
    Ask a Question
    K Number
    K050265
    Device Name
    CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
    Manufacturer
    CHRONO-LOG CORP.
    Date Cleared
    2005-10-14

    (252 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRONO-LOG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.
    Device Description
    The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.
    Ask a Question
    K Number
    K032951
    Device Name
    CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
    Manufacturer
    CHRONO-LOG CORP.
    Date Cleared
    2004-04-02

    (193 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRONO-LOG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Platelet Function testing of Whole Blood specimens using Impedance Aggregometry.
    Device Description
    The Chrono-log WBA, Model 591A/592A uses electrical impedance to measure platelet aggregation in a whole blood sample. The Impedance is measured using a Disposable electrode with two precious metal pins. A small voltage is applies across these two pins. When the electrode is placed into a diluted whole blood specimen and a monolayer is formed around the two pins. In the absence of an agonist, the platelet build-up stabilizes and a baseline is established. When an agonist is added to the specimen, the platelets begin to aggregate and collect on the electrode pins causing a change in impedance. The change of impedance is directly proportional to the amount of Aggregation in the specimen. This change of impedance is displayed on a front panel readout. The instrument has an analog output which produces an aggregation curve when connected to a strip chart recorder or AGGRO/LINK interface. Model 591 A is a single channel version; Model 592A is the duel channel version.
    Ask a Question
    K Number
    K962426
    Device Name
    CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
    Manufacturer
    CHRONO-LOG CORP.
    Date Cleared
    1996-10-22

    (120 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRONO-LOG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chrono-log WBA, Model 591/592 is intended for determination of platelet function in a whole blood specimen.
    Device Description
    The Chrono-log WBA, Model 591/592 uses electrical impediance to measure platelet aggregation in a whole blood sample. The Impedance is measured using an electrode with two platinum alloy wires. A small voltage is applies across these two wires. When the electrode is placed into a diluted whole blood specimen and a monolayer is formed around the two wires. In the absence of an agonist, the platelet build-up stabilizes and a baseline is established. When an agonist is added to the specimen, the platelets begin to aggreazate and collect on the electrode wires causing a change in impedance. The change of impedance is directly proportional to the amount of Aggregation in the specimen. The change of impedance is displayed on a front panel readout. An analog output which, when connected to a strip chart recorder, provides an aggregation curve. Model 591 is a single channel version; Model 592 is the duel channel version.
    Ask a Question

    Page 1 of 1