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The Immunalysis Ethyl Alcohol Enzyme Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum or plasma with automated clinical chemistry analyzers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This assay is calibrated against ethyl alcohol. This device is intended for prescription use only.

The Immunalysis Ethyl Alcohol Assay is based on the oxidation of ethyl alcohol to acetaldehyde by alcohol dehydrogenase (ADH) and nicotinamide adenine dinucleotide (NAD) reduced to NADH resulting in an absorbance change measured spectrophotometrically at 340nm. The concentration of ethanol in the sample is directly proportional to the ADH activity.

ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.

ALCO-SCREEN® is a visually read semi-quantitative test for the detection of alcohol in saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 5 different cut-off levels. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.

The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.

ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.

The EasyRA EtOH reagent is intended for the quantitative measurement of Alcohol (EtOH) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning. The EasyCal Ethanol Calibrator is intended for in-vitro diagnostic use for the calibration of the ethyl alcohol assay on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine. The EasyQC Ethanol quality control material is intended for in-vitro diagnostic use for the validation of the ethyl alcohol assay, which is used on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.

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The Teco Saliva Alcohol Test is a semi-quantitative screening test for measuring alcohol in human saliva. This strip specifies the relative Blood Alcohol Concentration (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results can be used for the indication of alcohol intoxication. For in vitro diagnostic use only. The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.

The Teco Saliva Alcohol Test is used to detect the amount of alcohol in the saliva after consumption. This is a semi-quantitative test that is read visually. The test strip determines the relative Blood Alcohol Concentration at 5 cut-off levels (negative, 0.02%, 0.04%, 0.08% and 0.3%). The device consists of a test strip (1 test strip per foil pouch). The resultant color on the test strip is compared to the color blocks printed on the pouch. The Teco Saliva Alcohol Test is a plastic strip tipped with a reactive pad containing tetramethylbenzidine, alcohol oxidase, and peroxidase. The test is utilizes two coupled enzymatic reactions to create the visual changes in the presence of varying amounts of saliva alcohol. The first reaction consists of an oxidation reaction where the ethanol in the saliva is converted to aldehyde by the alcohol oxidase. The second reaction is the oxidation of TMB, the color indicator substrate, and is catalyzed by the enzyme peroxidase. The color change of the pad corresponds to the amount of present alcohol in the sample. The results are read by comparing the colored pad to the color chart found on the strip package

Randox Ethanol Assay: The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This is an in vitro diagnostic device intended for prescription use only. Randox Ethanol Calibrator Set: The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™. Randox Ethanol Control Set: The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™. This is an in vitro diagnostic device intended for prescription use only.

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The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.

The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva at 0.0%, 0.02%, 0.08%, and 0.30% Blood Alcohol Concentration (BAC). Results are used in the diagnosis of alcohol intoxication. The test is a firm plastic strip with a test pad attached at the tip. The test pad contains chemicals that are highly sensitive to alcohol in saliva reacts with the chemicals to produce a color change on the test pad. The color change depends on the amount of alcohol present. The results are read by comparing the color of the test pad with the color chart. The test gives relative Blood Alcohol Concentration (BAC) from 0.02% to 0.30%.

The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

The Dimension® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.

The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

The Dimension Vista® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension Vista® System. The reagents contained in the Dimension Vista® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.

The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning. The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System. The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System. The Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. The Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. The Dimension Vista™ Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). The Dimension Vista™ Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.