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510(k) Data Aggregation

    K Number
    K053612
    Device Name
    DRI-STAT ACID PHOSPHATASE REAGENT
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2006-04-26

    (120 days)

    Product Code
    CKB
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
    Device Description
    The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.
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    K Number
    K023840
    Device Name
    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2003-01-07

    (50 days)

    Product Code
    CKB, JIX, JJY
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum. The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.
    Device Description
    The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.
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    K Number
    K991010
    Device Name
    ACP
    Manufacturer
    ABBOTT DIAGNOSTICS MFG., INC.
    Date Cleared
    1999-05-19

    (54 days)

    Product Code
    CKB
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in serum.
    Device Description
    Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.
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    K Number
    K981743
    Device Name
    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1998-06-09

    (22 days)

    Product Code
    CKB, CDO, CDQ, CEO, CFQ, CFR, CGS, CGX, CHH, CHJ, CIC, CIG, CIT, CIX, CJE, CZW, DCN, DEF, DGI, DHR, DOD, JFJ, JGJ, JGS, JHN, JIY, JJE, JLB, JMO
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.
    Device Description
    Photometric clinical chemistry analyzer
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    K Number
    K974695
    Device Name
    COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
    Manufacturer
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1998-05-21

    (156 days)

    Product Code
    CKB, JXM
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cassette COBAS INTEGRA Acid / Prostatic Phosphatase contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of total and prostatic acid phosphatase in serum. The cassette Roche COBAS INTEGRA Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the semi-quantitative detection of benzodiazepines in human urine using the enzyme ß-glucuronidase.
    Device Description
    The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
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    K Number
    K963640
    Device Name
    OLYMPUS ACID PHOSPHATASE REAGENT
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1997-02-18

    (159 days)

    Product Code
    CKB
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K943366
    Device Name
    IL TEST ACID PHOSPHATASE
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1996-01-29

    (565 days)

    Product Code
    CKB
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    CKB

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