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The S TEST Reagent Cartridge Calcium (CA) is intended for the quantitative determination of calcium in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Calcium is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. 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 Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28.mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Calcium. Chemistry reactions: Calcium in the sample combines with o-cresolphthalein complexone to form a purple-red complex. The concentration of calcium can be determined by measuring the absorbance of the resulting purple-red color. (With this method, the influence of magnesium is excluded by the addition of 8-hydroxyquinoline.)

The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessorcontrolled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used. Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

The Dimension® RxL Max® Chemistry System is a continuous operation chemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens and is a family member of the Dimension® XL Clinical Chemistry System (traditional 510(k) filed in 1994 K944093). The Dimension® RxL Max® Chemistry System has also been cleared with StreamLab Analytical WorkCell and Sample Transfer Module (K043546) The ADVIA® Modular Automation System (AMAS) is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory. AMAS is available as two products ADVIA® LabCell® and ADVIA® WorkCell. These LAS systems are made up of the same components and are controlled by common software. The systems differ in their expansion capabilities: ADVIA® WorkCell is an ADVIA® Automation solution that is limited to three fixed configurations supporting up to a total of five interface stations. ADVIA® LabCell® is customizable ADVIA® Automation solution that is configurable with up to 16 interface stations. Dimension® RxL Max® Chemistry System (Dimension) with Sample Transfer Module and the ADVIA® Modular Automation System combines the features of both the analyzer and the laboratory automation system. The ADVIA® Modular Automation System (AMAS) routes samples to the Dimension analyzer based on test request information received from the Laboratory Information System (LIS) and the test map established for the Dimension analyzer. AMAS and Dimension communicate sample and analyzer status via Dimension's Laboratory Automation System (LAS) interface. Via its Laboratory Information System (LIS) interface, the Dimension analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Dimension's test instructions and test results for each sample are not processed through the AMAS. AMAS performs the following pre and post-analytical functions. - Sample bar code identification (previously performed by the Dimension) . - Sample transport and tracking (pre-Analytical) . - Sample centrifugation (optional functionality) . - Sample de-capping (optional functionality) . - Sample transport and tracking (post-Analytical) . The Dimension continues to perform the following functions, when connected to AMAS. - All functions except reading the sample tube bar code. When Dimension is . connected to AMAS, samples can be loaded directly onto Dimension and/or loaded onto AMAS and routed to Dimension. For samples loaded onto the AMAS, which reads the sample tube bar code (sample identification) and passes it electronically to Dimension via the LAS interface.

ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. 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). ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Creatinine CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette, with two 28 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives. The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine based on an enzymatic photometric test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexe, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

The SPOTCHEM II Chemistry Basic 1 Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcum 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 SPOTCHEM II Chemistry Basic 1 Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. The SPOTCHEM II Chemistry Basic 1 Glucose test is intended to measure the glucose concentration in serum, plasma, and whole blood. 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 SPOTCHEM II Chemistry Basic 1 Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys. The SPOTCHEM II Chemistry Basic 1 Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The SPOTCHEM II Chemistry Basic 2 ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. The SPOTCHEM II Chemistry Basic 2 Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. The SPOTCHEM II Chemistry Basic 2 Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidray, or oo ne marrow, as well as other metabolic and nutritional disorders. The SPOTCHEM II Chemistry Basic 2 AST test is intended to measure AST activity in serum, plasma, and whole blood. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and head formants The SPOTCHEM II Chemistry Basic 2 ALT test is intended to measure ALT activity in serum, plasma, and whole blood. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

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The SpotChem II Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum 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 SpotChem II Magnesium test is intended to measure the concentration of magnesium in serum, plasma and whole blood. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The SpotChem II Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

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This reagent is intended for the quantitative determination of Calcium in serum, heparinized plasma, or urine. For in vitro diagnostic use only. This calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. The intended patient population may be adult, pediatric, and neonatal.

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The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).

The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.

The "Wiener lab. Ca-Color AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).

Calcium reacts with o-Cresolphtalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. magnesium 8-hydroxyquinoline is added to remove interference.

The calcium reagents: Buffer/Chromogen(R1), product No. CA110-01 and EDTA Reagent (R2), product No. CA110-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of calcium in serum, plasma and urine.

Buffer Chromogen (R1), EDTA Reagent (R2)