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CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders. HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

CHOLESTEROL: The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample. HDL-Cholesterol: The Accelerator Selective Detergent method is applied. The determination of HDL-Cholesterol is based on the following reactions: LDL, VLDL, and chylomicrons are neutralized by the combined action of the enzymes Cholesterol Oxidase, Peroxidase, accelerators and N,N-bis-(4-sulfobutyl)-m-toluidine-disodium (DSBmT). HDL remaining in the sample is disrupted by the action of a selective detergent and cholesterol is converted to △4 Cholestenone by the enzymatic action of Cholesterol Esterase and Cholesterol Oxidase, with the subsequent production of H2O2, which reacts with DSBmT and 4-aminoantipyrine in the presence of Peroxidase to a colored complex that absorbs light at 590 nm. The absorbance measured is proportional to the concentration of HDL-Cholesterol in the sample. LDL-Cholesterol: The Selective Detergent method is applied. The method is in a two-reagent format and depends on the properties of a unique detergent. The first detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. The second detergent solubilizes the remaining LDL particles, and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-Cholesterol in the presence of the coupler at 590 nm produces color that is proportional to the amount of LDL cholesterol present in the sample. TRIGLYCERIDES: The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.

The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes: The Lipid Profile GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density Ilpoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported. The TC+HDL GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood. The TC GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood. The Lipid Profile cassette is for the quantitative determination of total cholesterol. HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported. The TC+HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood. The TC cassette is for the quantitative determination of total cholesterol in whole blood. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Triglyceride measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. · Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette®. The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads. The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample. The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides. The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry. A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.

The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. The Cholesterol2 assay is to be used as an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Cholesterol2 assay is an automated clinical chemistry assay for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide oxidatively couples with N,N-Bis(4-sulfobutyl)-3-methylaniline (TODB) and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which is quantitated at 604 nm.

The FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips. The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use). Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions). The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (k161738).

The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. A Chol/HDL ratio is calculated by the CardioChek Plus analyzer. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. A Chol/HDL ratio is calculated by the CardioChek Plus analyzer. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels eGlu test strips) is for the quantitative determination of glucose in venous whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. A Chol/HDL ratio is calculated by the CardioChek Plus Home analyzer The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. A Chol/HDL ratio is calculated by the CardioChek Plus Home analyzer. The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. · Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Home Analyzer. The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home eGlu test strips) is for the quantitative determination of glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The CardioChek Plus and CardioChek Plus Home analyzers are professional (Rx) use (CardioChek Plus) and home use/OTC (CardioChek Plus Home) in vitro diagnostic systems to measure various analytes in capillary fingerstick whole blood for both home and professional use and in venous whole blood for professional use only for glucose, cholesterol, HDL cholesterol, and triglycerides. The system includes a small analyzer and test strips. The analyzers utilize PTS Diagnostics brands of dry strip chemistry test strips. The test strips are single-use and utilize one of two types of technologies: reflectance photometry and amperometric/electrochemical technology. The test strips are used with the CardioChek Plus and CardioChek Plus Home analyzers to measure total cholesterol, HDL cholesterol, triglycerides, and glucose in whole blood. The test strips utilize enzymatic methods on dry colorimetric test strips that are read by reflectance photometry or amperometric/electrochemical test strips that measure the current produced when blood is applied to the test strip. These test strips are for in vitro diagnostic use only. The analyzer has software that converts the reflectance or current produced into an analyte concentration by comparing the reading to a lot-specific calibration curve that is programmed into a EEPROM MEMo chip that is inserted into the analyzer. Each vial of test strips includes a lot-specific MEMo chip, thus eliminating any need for the user to calibrate the system. The analyzer is powered by 4 AA alkaline batteries.

Rx Only For in vitro diagnostic use only The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders. The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte. To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry. To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.

The PTS Professional Chemistry Kit is a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in capillary (fingerstick) or venous whole blood. · Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. · HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. · Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. • The HbA1C test provides quantitative measurement of the percent of glycated hemoglobin levels. The test is for professional use to monitor glycemic control in people with diabetes.

The PTS Professional Chemistry Kit combines devices that are already cleared and packages them together for the convenience of the user. There are two CardioChek® Analyzers: the CardioChek® PA Analyzer and the CardioChek® Plus Analyzer. These analyzers are part of portable test systems. The CardioChek® PA test system and the CardioChek® Plus test system consist of their respective analyzer and PTS Panels® Test Strips with a lotspecific MEMo® Chip. The CardioChek® PA and Plus test systems are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and are intended for multiple patient uses in professional healthcare settings. These systems are for in vitro diagnostic use only. The PTS Panels® Test Strips consist of varying amounts of test strips packed into a vial and a lot-specific MEMo® Chip. PTS Panels® Test Strips include reflectance and electrochemical test strips. The reflectance assays include quantitative determination of glucose, total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides. The electrochemical assay is for glucose measurement. The reflectance test strips are available with one, two, and three assays and come in various combinations of assays. The included PTS Panels® Test Strips include: PTS Panels® Lipid Panel Test Strips, PTS Panels® Chol+HDL+Glu Test Strips, PTS Panels® Chol+HDL Test Strips, PTS Panels® Chol+Clu Test Strips, PTS Panels® eGlu Test Strips, PTS Panel® Glucose Test Strips, and CardioChek Plus Smart Bundle™ Pack. The PTS Panels® Test Strips are single-use. PTS Panels® Controls contain chemicals that react with test strips to produce color or an electrical current depending on the test strips used. Controls should be run to verify the test system performance, when results are questionable, to comply with a facility's quality control requirements, or as required by local accrediting and regulatory bodies. They contain two vials of control solution that have two levels of each analyte. Controls included in this kit are the PTS Panels® HDL Cholesterol Controls and PTS Panels® Multi-Chemistry Controls. The PTS Collect™ Capillary Tubes are a glass and plastic tube capable of dispensing an exact volume of blood from the capillary tube to a test strip. The tubes are available with volumes of 15, 20, 30, and 40 uL. The A1CNow + test provides quantitative measurement of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. A1CNow®+ consists of three components: a semi-disposable plastic-encased device (the analyzer), a plastic cartridge enclosing dry reagent strips, and a shaker kit. The units of the analyzer are pre-programmed on the analyzer and are available in either percentage of glycated hemoglobin (%A1C) or millimoles per mole (mmol/mol). The analyzers are lot specific and intended to be discarded once the provided cartridges are consumed. The Unistik® 3 Pre-set Single Use Safety Lancets are sterile, single-use, auto-disabling lancets to perform finger sticks to obtain capillary blood. The PTS Connect™ Dock and PTS Connect® ProLink are included to transfer data from the CardioChek® Plus Analyzer, CardioChek® PA Analyzer, and the A1CNow®+ to computer systems. The CardioChek® Printer interfaces with the CardioChek® Plus and CardioChek® PA Analyzer to print results onto paper and self-adhesive labels. The PTS Professional Chemistry Kit contents are customizable according to user needs. Individual kits may not contain all the devices described in this submission.

The Extended Lipid Panel Assay is an in vitro diagnostic test for quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human serum and Apolipoprotein B in human serum. Values for Total Cholesterol, High Density Lipoprotein Cholesterol, Triglycerides and Apolipoprotein B are calculated by the Vantera® Clinical Analyzer. · Total Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders. · High Density Lipoprotein Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. · Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. · Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

The Extended Lipid Panel Assay involves the acquisition of a 400 MHz proton NMR spectrum of serum or plasma, passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model. The proton NMR spectrum of serum and plasma is replete with information from the lipids packaged in lipoproteins. The spectrum consists of multiple proton signals emanating from the TG, cholesteryl esters and free cholesterol present in chylomicrons, VLDL, LDL and HDL, out of which the methylene and methyl proton signals are the most abundant. NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured. Using a PLS regression routine, the spectral information in the combined methylene and methyl region (0.56 - 1.40 ppm) was trained against the chemical measurements where the information is connected through latent variables. Cross-validation was performed with PRESS statistics to optimize the regression model with an appropriate number of latent variables. Once trained with sufficient number of specimens, for any test specimen spectrum, the spectral information is then converted into lipid or ApoB concentrations through the optimum number of 24 to 27 latent variables for which the regression coefficients were known from the predictor matrix.

The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingerin venous whole blood. The Mission® Lipid Panel Monitoring System consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission® Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto disabling lancing devices. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro Meter and is reported only when Triglycerides are ≤400 mg/dL.

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SD LipidoCare BT Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use). The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LipidoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared. SD LipidoCare BT Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use). The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare BT Professional Blood Glucose Test Strips are for use with SD LipidoCare BT Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professionals. SD LipidoCare BT Profile Test Strips are intended for use with the SD LipidoCare BT Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals. SD LipidoCare Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use). The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LipidoCare Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared. SD LipidoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use). The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatments with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare (BT) Professional/Home Analyzer can measure TC, TG, HDL, and Glucose, and it also can calculate LDL and non-HDL using the blood sample from the human with the SD LipidoCare (BT) Profiessional/Home Lipid Profile and SD LipidoCare (BT) Professional/Home Glucose test strips. This system is portable using batteries for power source and can store up to 500 test results in the memory. Users can search the stored results and can review the average results for 7, 15 and 30 day glucose test results. The average calculation function is for glucose test results only. This system can set the beep, date, time, unit, auto printing, simplex/duplex printing, hypo warning for glucose, alarms and Bluetooth. The analyzer offers 2 models: one with Bluetooth function for printing the test results and transferring data to a PC via Bluetooth technology and the other without it. The analyzer without the Bluetooth unit can still print the test results and transfer the data to a PC using a cable. The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor. There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing. The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.