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510(k) Data Aggregation

    K Number
    K973448
    Device Name
    ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-09-17

    (371 days)

    Product Code
    LGD
    Regulation Number
    866.3780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
    Device Description
    The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
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    K Number
    K982250
    Device Name
    ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-07-14

    (18 days)

    Product Code
    CEC, JIS
    Regulation Number
    862.1695
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCESS® Free T4 Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human or plasma (heparin) using the ACCESS® Immunoassav System. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
    Device Description
    The ACCESS® Free T4 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free thyroxine in human serum or plasma (heparin).
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    K Number
    K981403
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-05-08

    (21 days)

    Product Code
    DKB
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Valproic Acid (VPA) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.
    Device Description
    The IMMAGE Immunochemistry System VPA Reagent in conjunction with Beckman Drug Calibrator 1, is intended for use in the quantitative determination of valproic acid in human serum or plasma on Beckman Coulter's IMMAGE Immunochemistry Systems.
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    K Number
    K981354
    Device Name
    ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-05-01

    (17 days)

    Product Code
    LOJ
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein (AFP) in human serum using the Access Immunoassay System. AFP measured by the Access AFP Immunoassay, is used as an aid in the management of patients with nonseminomatous testicular cancer.
    Device Description
    The ACCESS® AFP Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of AFP in human serum.
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    K Number
    K980173
    Device Name
    ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-03-18

    (57 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCESS® Total βhCG assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of total βhCG in human serum, using the the ACCESS® Immunoassay System.
    Device Description
    The Access® Total BhCG reagents and the Access® Immunoassay Analyzer comprise the Access® Immunoassay System for the quantitative determination of total βhCG levels in human serum.
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    K Number
    K974816
    Device Name
    ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-02-20

    (59 days)

    Product Code
    LTJ
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS Immunoassay System. PSA measured by the Access PSA Immunoassay, is used as an aid in the management of patients with prostate cancer.
    Device Description
    The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.
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    K Number
    K974564
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-02-17

    (74 days)

    Product Code
    DEB
    Regulation Number
    866.5620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Alpha~Macroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha~ macroglobulin by rate nephelometry. Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
    Device Description
    The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.
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    K Number
    K974110
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-12-24

    (54 days)

    Product Code
    JBQ, DDQ
    Regulation Number
    864.7060
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.
    Device Description
    The IMMAGE Immunochemistry System AT3 Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Antithrombin III concentrations on Beckman's IMMAGE Immunochemistry System.
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    K Number
    K974452
    Device Name
    VIGIL LIPID CONTROL
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-12-17

    (22 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.
    Device Description
    The VIGIL™ Lipid Controls are four level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 4 X 4 mL bottles of a single level of control.
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    K Number
    K973932
    Device Name
    BECKMAN CALIBRATOR 2 (CAL2)
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-12-15

    (61 days)

    Product Code
    JIX, CZP, DCF, DDB, DEB, JBQ, JZG
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha,-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alphamacroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
    Device Description
    Beckman Calibrator 2 is derived from fresh frozen human plasma that has been defibrinated and processed. Assay of CAL 2 provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which AAT, CER, PFB, B2M, AMG, and AT3 concentration values are determined for test specimens.
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