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510(k) Data Aggregation

    K Number
    K211648
    Device Name
    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2022-09-08

    (468 days)

    Product Code
    DFH, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diazyme Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only. The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
    Device Description
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    K Number
    K220001
    Device Name
    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2022-08-04

    (212 days)

    Product Code
    DFH, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diazyme Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only. The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
    Device Description
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    K Number
    K212221
    Device Name
    Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2021-12-13

    (150 days)

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

    Diazyme Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diazyme DZ-Lite iFlash Total BhCG Assay is a chemiluminescent immunoassay intended for use for the quantitative determination of total beta-human chorionic gonadotro pin (total BhCG) in human serum on DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer. The assay is intended for use as an aid in the early detection of pregnancy. Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer is used clinically in combination with the supporting chemiluminescence immunoassay reagents for determination of analytes in human body fluids through acridinium ester-based chemiluminescence method.
    Device Description
    Diazyme DZ-Lite iFlash Total BhCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
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    K Number
    K203136
    Device Name
    Diazyme PLAC® Test for Lp-PLA2 Activity
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2021-08-06

    (290 days)

    Product Code
    NOE
    Regulation Number
    866.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diazyme Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
    Device Description
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    K Number
    K180209
    Device Name
    Diazyme 1,5-AG Assay
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2018-10-04

    (253 days)

    Product Code
    NOZ
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diazyme Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.
    Device Description
    Diazyme's 1.5-AG assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphoralated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate.
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    K Number
    K181438
    Device Name
    Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2018-06-26

    (25 days)

    Product Code
    DFH, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diazyme Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only. The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only.
    Device Description
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