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510(k) Data Aggregation

    K Number
    K241220
    Device Name
    Tina-quant Lipoprotein(a) Gen.2 Molarity
    Manufacturer
    Roche Diagnostics Operations
    Date Cleared
    2025-01-24

    (268 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a]] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.
    Device Description
    The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests. Tina-quant Lipoprotein (a) Gen.2 Molarity assay quantifies lipoprotein (a) in human serum and plasma and reports the values in nmoVL with calibrator values traceable to the WHO/IFCC SRM2B reference material. Reagents - working solutions R1: Glycine buffer: 170 mmol/L. pH 7.0: stabilizers: BSA: rabbit serum 0.1 %, preservative R3: Latex particles coated with polyclonal anti-human lipoprotein (a) antibodies (rabbit): 0.5 %; glycine buffer: 170 mmol/L, pH 7.3, BSA; preservative
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    K Number
    K211058
    Device Name
    Lp(a) Ultra
    Manufacturer
    Sentinel CH. SpA
    Date Cleared
    2022-12-22

    (622 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitation of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.
    Device Description
    Lp(a) Ultra assay is composed by 2 ready to use liquid reagents (Reagent 1and Reagent 2) that are supplied in the following configuration: Reagent 1 fill volume 18 mL in a 20 mL wedge and Reagent 2 fill volume 9 mL in a 20 mL wedge, 1 wedge of each/kit. The kit contains one plastic (HDPE) vial of Reagent 1 and one plastic (HDPE) vial of Reagent 2, which allows the customer to perform 86 tests (on AU680 automatic analyzer).
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    K Number
    K180074
    Device Name
    Diazyme Lipoprotein (a) Assay
    Manufacturer
    Diazyme Laboratories, Inc.
    Date Cleared
    2018-03-22

    (71 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K123046
    Device Name
    ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2012-12-20

    (83 days)

    Product Code
    DFC, JIT
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use in the quantitative measurement of lipoprotein(a) (Lp(a)) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat) metabolism and assessing persons at risk for cardiovascular diseases when used in conjunction with clinical evaluation and other lipoprotein tests. The ADVIA® Chemistry Lipoprotein(a) calibrators is intended for use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry Lipoprotein(a) (LPA) assay.
    Device Description
    The Lipoprotein(a) reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Lipoprotein(a) calibrator is a single analyte, human serum based product containing human lipoprotein (a). The kit consists of 1 vial each of 5 calibrator levels which are lyophilized. The target concentrations of these calibrators are 7.5, 15, 30, 65, and 95 mg/dL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
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    K Number
    K122722
    Device Name
    COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2012-11-29

    (85 days)

    Product Code
    DFC, JIT, JJX
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
    Device Description
    The TQ Lp(a) Gen.2 test principle is a particle-enhanced immunoturbidimetric assay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically. The Preciset Lp(a) Gen.2 calibrator set consists of five lyophilized calibrators based on a stabilized and lyophilized pool of human plasma. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. The PreciControl Lp(a) Gen.2 control set contains two lyophilized controls based on a human plasma matrix.
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    K Number
    K082488
    Device Name
    DIAZYME LP(A) ASSAY
    Manufacturer
    GENERAL ATOMICS
    Date Cleared
    2009-01-13

    (138 days)

    Product Code
    DFC, JIT, JJX
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum er plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry. Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.
    Device Description
    The Diazyme Lipoprotein (a) Assay is based on a latex enhanced immunoturbidimetric assay. Lp(a) in the sample binds to specific anti-Lp(a) antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lp(a) in the sample.
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    K Number
    K063838
    Device Name
    LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-09-27

    (275 days)

    Product Code
    DFC, JIT, JJY
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.
    Device Description
    Not Found
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    K Number
    K050487
    Device Name
    QUANTIA LA(A)
    Manufacturer
    BIOKIT S.A.
    Date Cleared
    2005-04-26

    (60 days)

    Product Code
    DFC, JIS, JJX
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry. Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
    Device Description
    The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry. Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
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    K Number
    K023853
    Device Name
    K-ASSAY LP(A) CONTROLS
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-12-13

    (24 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.
    Device Description
    Not Found
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    K Number
    K021660
    Device Name
    K-ASSAY LP(A) ASSAY
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-07-25

    (66 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Product Code :

    DFC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations. The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay. For in vitro diagnostic use.
    Device Description
    Not Found
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