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510(k) Data Aggregation

    K Number
    K061775
    Device Name
    WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2007-02-23

    (245 days)

    Product Code
    JFY, JIT
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The L-Type Creatinine-M is an in-vitro assay for the quantitative determination of creatinine in serum, plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
    Device Description
    L-Type Creatinine M is a reagent kit for creatinine assay based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase and N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) as a new color agent.
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    K Number
    K062368
    Device Name
    WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2007-01-31

    (170 days)

    Product Code
    OAU, JIT, JJX
    Regulation Number
    866.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment.
    Device Description
    The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys". This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement.
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    K Number
    K053131
    Device Name
    WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2005-12-30

    (52 days)

    Product Code
    JFM
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
    Device Description
    Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidating agent, shows good correlation with conventional methods, practically no interference by coexistent serum and plasma substances, and is convenient ready-to-use liquid type reagent. When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.
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    K Number
    K053132
    Device Name
    WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2005-12-30

    (52 days)

    Product Code
    JFM, LFM
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
    Device Description
    When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.
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    K Number
    DEN050002
    Device Name
    LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2005-05-19

    (42 days)

    Product Code
    NSF, TES
    Regulation Number
    866.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wako AFP-L3% assay is intended as a risk assessment test for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases (CLD). Elevated AFPL3% values (≥ 10%) have been shown to be associated with a seven-fold increase in the risk of developing HCC within the next 21 months. Patients with elevated serum AFPL3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.
    Device Description
    The Wako AFP-L3% device consists of reagent 1 (LCA and anion 1-conjugated anti-AFP mouse monoclonal antibody), reagent 2 (horseradish peroxidase (POD)labeled anti-AFP mouse monoclonal antibody and anion 2 conjugated anti-AFP mouse monoclonal antibody, substrate 1 (4 acetamidophenol in 2-propanol) and substrate 2 (hydrogen peroxide) and a column. Reagent 1, reagent 2 and the column are ready-to-use. Elution buffers A to C, sample cups, inside and outside cuvettes are sold separately from kit. The Wako AFP-L3 Calibrator set and Control set are sold separately. The calibrator set consisted of Calibrator 1 and 2. Calibrator 1 contains human AFP -L1 fraction and Calibrator 2 has human AFP-L3 fraction. The control set consisted of Control 1 and 2, each containing different concentrations of human AFP-L1 and L-3.
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    K Number
    K042551
    Device Name
    MULTI-CHEM CALIBRATOR A
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-11-16

    (57 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.
    Device Description
    Not Found
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    K Number
    K042549
    Device Name
    MULTI CHEM CAL B
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-11-08

    (49 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-Chem Calibrator B is designed to be used with Wako's assays to determine the points of reference that are used in the determination of Glucose, Uric Acid and Urea N in human serum.
    Device Description
    Not Found
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    K Number
    K042550
    Device Name
    MULTI-LIPID CALIBRATOR
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-11-08

    (49 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.
    Device Description
    Not Found
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    K Number
    K040918
    Device Name
    WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-05-17

    (39 days)

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

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wako Quality Control is intended for use as an assay quality maroations in of ooo. The transecision of laboratory testing procedures for the Wako Control scrain to monitor the processor of L-Cholesterol, LDL-Cholesterol, lipid assuy cash as Thigyonins, NEFA C, Free Cholesterol and beta Lipoprotein assays.
    Device Description
    Not Found
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    K Number
    K033860
    Device Name
    AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-04-23

    (133 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAKO CHEMICALS, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wako Total Ketone Body Calibrators are intended to be used with the Wako Autokit Total Ketone Body products and instruments to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-hydroxybutyrate in human serum or plasma.
    Device Description
    Not Found
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