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510(k) Data Aggregation
K Number
K162593Device Name
HDL-Cholesterol Gen.4
Manufacturer
Roche Diagnostics Operations (RDO)
Date Cleared
2016-10-19
(33 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Device Description
The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.
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K Number
K153435Device Name
Direct HDL Cholesterol (HDL)
Manufacturer
Randox Laboratories Ltd
Date Cleared
2016-01-08
(42 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and renal diseases and for the assessment for the risk of developing cardiovascular disease.
This in vitro diagnostic device is intended for Rx Only.
Device Description
The Direct HDL Cholesterol (HDL) kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CH8311
R1. Enzyme Reagent 1 4 x 20 ml
R2. Enzyme Reagent 2 4 x 9 ml
REAGENT COMPOSITION
R1. Enzyme Reagent 1 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid N-(2-hydroxy-3-Sulfopropyl)- 3,5-dimethoxyaniline, sodium salt (HDAOS) Cholesterol Esterase [E.C.3.1.1.13. Microorganism] Cholesterol Oxidase [E.C.1.1.3.6. Streptomyces sp] Catalase [E.C.1.11.1.6. Microbial] Ascorbate oxidase [EC.1.10.3.3. Acremonium sp.] Initial Concentration of Solution 100 mM, pH 6.6 (+25 °C) 0.7 mM ≥800 U/L ≥500 U/L ≥300 KU/L ≥3000 U/L
R2. Enzyme Reagent 2 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid 4-Aminoantipyrine Peroxidase [E.C.1.11.1.7, Horse Radish, +25°C] Sodium Azide Surfactants Initial Concentration of Solution 100 mM, pH 7.0 (+25 °C) 4.0 mM ≥3500 U/L 0.05 w/v % 1.4 % w/v %
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K Number
K132711Device Name
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
2014-05-08
(252 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative determination of high-density lipprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC720® Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
Device Description
Not Found
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K Number
K120609Device Name
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Date Cleared
2012-09-07
(191 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5, I FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
Device Description
The VITROS dHDL assay is performed using the VITROS Chemistry Products dHDL Slide and the VITROS Chemistry Products Calibrator Kit 25 on the VITROS Chemistry Systems. The VITROS dHDL Slide is a multi-layered analytical element coated on a polyester support. The method is based on a non-HDL precipitation method followed by an enzymatic detection. All reactions necessary for a single quantitative measurement of HDLC take place within the multi-layered analytical element of a VITROS Chemistry Products dHDL Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately generates a colored dye. The density of dye formed is proportional to the HDL Cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.
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K Number
K111516Device Name
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Manufacturer
LIPOSCIENCE, INC
Date Cleared
2011-09-27
(118 days)
Product Code
LBS, CDT, MRR
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NMR LipoProfile® test, when 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 human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides 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 and NMR Profiler involves measurement of the 400 MHz proton NMR spectrum of a plasma/serum sample, deconvolution of the composite signal at approximately 0.8 ppm to produce signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma/serum 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 LDL, HDL and VLDL subclasses of varying diameters. The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which is 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 assuming 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
K103747Device Name
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
Manufacturer
ELITECHGROUP SEPPIM S.A.S.
Date Cleared
2011-08-31
(251 days)
Product Code
LBS, JIT, JJY, MRR
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II on ELITech Clinical Systems Selectra analyzers for the quantitative in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Device Description
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: Good's buffer, Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), Ascorbate oxidase (bacterial), N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator. Reagent R2 contains: Good's buffer, Cholesterol esterase (CHE bacterial), 4-Amino-Antipyrine (4-AA), detergent.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including high density lipoproteins and sodium azide as preservative. CHOLESTEROL HDL 2G CALIBRATOR is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), 4-Amino-Antipyrine (4-AA), Ascorbate oxidase (vegetal). Reagent R2 contains: MES buffer, Detergent 2, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT).
ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including low density lipoproteins and sodium azide as preservative. CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor units tested individually by FDA - approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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K Number
K111036Device Name
EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
Manufacturer
MEDICA CORPORATION
Date Cleared
2011-07-12
(89 days)
Product Code
LBS, CDT, CHH, MRR
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only.
The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, 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. For in vitro diagnostic use only.
The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only.
The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only.
Device Description
Not Found
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K Number
K100550Device Name
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
Manufacturer
POLYMEDCO, INC.
Date Cleared
2010-09-28
(214 days)
Product Code
LBS, CDT, CHH, MRR
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Poly-Chem 90 Direct HDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure high density lipoproteins quantitatively in human serum on the Poly-Chem 90 analyzer. HDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.
The Poly-Chem 90 Direct LDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure low density lipoprotens quantitatively in human serum on the Poly-Chem 90 analyzer. LDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.
The Poly-Chem 90 Cholesterol test system is an in vitro diagnostic procedure intended to measure cholesterol quantitatively in human serum on the Poly-Chem 90 analyzer. Cholesterol measurements are used in the diagnosis and treatment of lipid disorders, lipoprotein metabolism disorders and atherosclerosis.
The Poly-Chem 90 Triglycerides test system is an in vitro diagnostic procedure intended to measure triglyceride quantitatively in human serum on the Poly-Chem 90 analyzer. Triglycerides measurements are used in the diagnosis and treatment of disease involving lipid metabolism and various endocrine disorders e.g. diabetes mellitus, nephrosis and liver obstruction.
Device Description
Not Found
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K Number
K100010Device Name
HDL CHOLESTEROL (HDLX) ASSAY
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2010-05-14
(130 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.
HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
Device Description
HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.
HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
This direct HDL Cholesterol method is a homogeneous assay without the need for any offline pretreatment or centrifugation steps. The method depends on a unique detergent which solubilizes only the HDL lipoprotein particles and releases HDL cholesterol to react with cholesterol esterase and cholesterol oxidase in the presence of chromogens, to produce a color product. The same detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicrons lipoproteins by adsorbing to their surfaces. A polyanion contained in the reagent enhances the selectivity for HDL cholesterol assay by complexing LDL, VLDL, and chylomicrons lipoproteins.
HDLX reagent is used to measure the cholesterol concentration by a timed-endpoint method. The SYNCHRON® System(s) automatically proportions the appropriate HDL cholesterol sample and reagent volumes into a cuvette. The ratio used is one part sample to 93 parts reagent. The System monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration.
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K Number
K080125Device Name
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
Manufacturer
WAKO CHEMICALS USA, INC.
Date Cleared
2008-07-18
(183 days)
Product Code
LBS, CDT, CGO, JJE
Regulation Number
862.1475Why did this record match?
Product Code :
LBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.
APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.
The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.
Device Description
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
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