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510(k) Data Aggregation

    K Number
    K241800
    Device Name
    Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2024-07-26

    (35 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K210801
    Device Name
    AXINON® LDL-p Test System
    Manufacturer
    numares AG
    Date Cleared
    2023-07-19

    (854 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXINON® LDL-o Test System is intended to measure lipoprotein particles to quantify LDLp) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample. LDL-p concentration values are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease. This test system is for professional use only.
    Device Description
    The AXINON® LDL-p Test System involves measurement of the 600 MHz proton NMR spectrum of a serum sample, deconvolution of the composite signal at approximately 0.85 ppm to produce signal amplitudes of lipoprotein subclass proportions that contribute to the composite serum signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations. The 0.85 ppm serum NMR signal arises mainly from the methyl group protons of the lipids carried in the VLDL, LDL and HDL subclasses of varying diameters. The NMR signals from the various lipids within the lipoprotein subclasses have unique and distinctive shapes and frequencies, uncovered by the granular decomposition of the composite serum signal. Each of these lipid signal representatives is proportional to the number of subclass particles emitting the signal, which enables subclass particle concentrations to be calculated from the subclass signal amplitudes derived from the spectral deconvolution analysis. LDL subclass particle concentrations, in units of nanomoles of particles per liter (nmol/L), are summed to give the reported total LDL particle concentration (LDL-p). The AXINON® LDL-p Test System including the AXINON® Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically human serum. The AXINON® Analyzer system is distributed across two separate computers: The workstation running AXINON® Software is the main host of the system. It controls user interfaces, data handling, results calculation, schedules and manages all activities required to process a sample, and manages remote access to the NMR system. In addition, AXINON® Analyzer comes with the optional software utility AXINON® Sample Wizard that supports manual sample preparation procedures. The NMR workstation controls all magnet operations and the hardware in the sample handler.
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    K Number
    K161691
    Device Name
    Direct LDL Cholesterol (LDL)
    Manufacturer
    RANDOX LABORATORIES LIMITED
    Date Cleared
    2017-03-20

    (273 days)

    Product Code
    MRR
    Regulation Number
    862.1475
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    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases. This in vitro diagnostic device is intended for prescription use only.
    Device Description
    The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312 R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
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    K Number
    K091333
    Device Name
    S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
    Manufacturer
    ALFA WASSERMANN, INC.
    Date Cleared
    2009-08-03

    (89 days)

    Product Code
    MRR
    Regulation Number
    862.1475
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    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
    Device Description
    The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.
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    K Number
    K090734
    Device Name
    EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2009-07-17

    (120 days)

    Product Code
    MRR, JIX, JJY
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyRA dLDL reagent is intended for the quantitative determination of Low Density Lipoproteins in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The EasyRA dLDL calibrator facilitates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent. The dLDL calibrator is used to establish a point of reference that is used in the determination of values in the measurement of LDL Cholesterol in human serum. The EasyRA EasyQC material validates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent and calibrator. The EasyQC is used to estimate test precision and to detect systemic analytical deviations that may arise from reagent or analytical instrument variation.
    Device Description
    Not Found
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    K Number
    K063841
    Device Name
    NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
    Manufacturer
    LIPOSCIENCE
    Date Cleared
    2008-07-23

    (575 days)

    Product Code
    MRR, CDT, JIT, JJY, LBS
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NMR LipoProfile® -2 test, used with the NMR Profiler, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of triglycerides and HDL-C are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease. This test is performed and provided as a service by LipoScience Laboratory.
    Device Description
    The NMR LipoProfile Test involves measurement of the 400 MHz proton NMR spectrum of a plasma or serum sample, deconvolution of the composite signal at ~0.8 ppm to produce the signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations. The 0.8 ppm plasma NMR signal arises from the methyl group protons of the lipids carried in the VLDL, and HDL subclasses of varying diameter. The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which are accounted for in the deconvolution analysis model. Each subclass signal amplitude is proportional to the number of subclass particles emitting the signal, which enables subclass particle concentrations to be calculated from the subclass signal amplitudes derived from the spectral deconvolution analysis. LDL subclass particle concentrations, in units of nanomoles of particles per liter (nmol/L), are summed to give the reported total LDL particle concentration (LDL-P). By employing conversion factors that assume that the various lipoprotein subclass particles have cholesterol and triglyceride contents characteristic of normolipidemic individuals, HDL cholesterol and triglyceride concentrations are also derived.
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    K Number
    K051121
    Device Name
    DIRECT LDL CHOLESTEROL, MODEL L530-60H
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2005-08-08

    (98 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K043264
    Device Name
    LDL-EX SEIKEN ASSAY KIT
    Manufacturer
    DENKA SEIKEN CO., LTD.
    Date Cleared
    2005-01-26

    (63 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.
    Device Description
    The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The LDL-EX SEIKEN Assay Kit is a homogeneous method for directly measuring LDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.
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    K Number
    K041927
    Device Name
    LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-11-23

    (127 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
    Device Description
    Not Found
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    K Number
    K041720
    Device Name
    VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
    Manufacturer
    Ortho-Clinical Diagnostics, Inc.
    Date Cleared
    2004-08-25

    (62 days)

    Product Code
    MRR, JIT, JJX
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MRR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents. For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
    Device Description
    The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays. The system is comprised of four main elements: 1. The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924). 2. The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay. 3. The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924). 4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent). The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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