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Clinical Chemistry - The Sentinel Clin Chem Cal is a device intended for medical purposes for use in Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" assays to establish points of reference that are used in the determination of values in the measurement of Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" in human specimens.

The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucainedi in a lyophilized human serum matrix. This material is stable until the date printed on the label when stored as directed.

The Sentinel Pancreatic Amylase is used for the quantitation of pancreatic amylase levels in human serum or plasma. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). For In Vitro use only.

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The Sentinel Pancreatic Amylase is a two-reagent format that is carried out in two successive steps. In the first incubation step, the activity of the human salivary alpha-amylase is inhibited using two different monoclonal antibodies with no effect on the pancreatic alpha-amylase. In the second reaction step, the pancreatic alpha-amylase catalyses the hydrolysis of the EPS substrate (Ethylidene Protected Substrate) p-nitrophenyl-maltoheptaoside 4,6ethylidene-blocked (Ethylidene-G7PNP) forming 2 ethylidene-G4 + 2 G3PNP + ethylidene-G3 + G4PNP. The a-glycosidase hydrolyses all fragments of G2PNP. G3PNP, and G4PNP into p-nitro phenol (PNP) and glucose (G). The increase of absorbance, due to PNP formation, is proportional to the activity of pancreatic alphaamylase in the examined sample.

The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome. The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.

The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) submission is composed by reagent, calibrator and controls, packaged and distributed in different kits. The device is intended to be sold as an in-vitro test for professional use. The Ammonia Ultra is an enzymatic in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. Ammonia, in the presence of glutamate dehydrogenase (GLDH), combines with alpha-ketoglutarate and NADH to yield glutamate and NAD*. The decrease in absorbance due to the NADH oxidation, at 340 nm, is proportional to the ammonia concentration in the examined plasma. The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 microgram/dL included in the kit. To ensure a correct determination during quantification of ammonia samples, a quality control procedure is required. The Ammonia Controls are liquid controls at 3 levels, prepared in bovine albumin matrix, and are used to verify the performance of the Ammonia Ultra assay. The value and range assigned to each level is specific for each lot and has been determined in rigorously standardized condition by the calculation of the median obtained in multiple determinations using reagents and standard relative to the Ammonia Ultra.

The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

The Sentinel UIBC Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use. Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.

Clinical Chemistry – The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.

The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma. Sentinel Clin Chem Cal contains the analytes in human serum matrix. The analytes consist of pancreatic amylase and cholinesterase.

The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.

Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.

The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

The Iron Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use. The Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of iron without deproteinization in human serum and plasma (heparin salt, only). In a pH 4.0 buffer system, iron is released from transferin to which it is bound, and then quantitatively reduced to a ferrous state. The iron forms with Ferene-S a stable colored complex of which the color intensity is proportional to the amount of iron in the sample. Particular reaction conditions and a specific masking agent eliminate the interference from copper.

CRP Vario is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. CRP Calibrators (CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum and EDTA or lithium heparinized plasma samples. CRP Control US is intended for use as an assayed quality control material for serum C-reactive protein analysis.

The Sentinel CRP Vario kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein (CRP) in human serum and in heparinized and EDTAplasma. Human CRP antigens in the sample bind to the specific anti-CRP antibody absorbed to latex particles, and agglutination occurs. This agglutination is detected as an absorbance change when read on an automated chemistry analyzer at wavelengths between 550 - 580 nm. The magnitude of the change in absorbance is proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration using the CRP Calibrator Set, CRP Calibrator US, or CRP Calibrator WR. The Sentinel CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR are prepared by diluting purified CRP with normal human serum to reach CRP concentrations of 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 and 48.0 mg/dL. By using the CRP Vario with the Sentinel calibrator kits, each used with specific analyzer settings called Methods, three measuring ranges can be achieved. The combinations of calibrators, method used and analytical ranges are listed in Table 5.1. The Standard and the Wide Range Methods can be used with any available commercial quality control materials. The CRP Vario with the Ultrasensitive Method requires a Sentinel control, CRP Control US, for the approximate CRP concentration of 0.05 mg/dL to ensure the effectiveness of CRP measurements at very low CRP concentrations.

The Sentinel Plasmaproteins Cal 3x is a device intended for medical purpose for use in ceruloplasmin, kappa light chains and lambda light chains assay to establish points of reference that are used in the determination of values in the measurement of ceruloplasmin, kappa and lambda light chains in human serum and plasma.

Sentinel Plasmaproteins Cal 3x contains analytes (plasmaproteins) in human serum matrix. The analytes consist of ceruloplasmin, kappa light chains, and lambda light chains.

The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.