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1. VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. 2. VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. 3. VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. 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 VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Alinity c ICT Sample Diluent is a reagent kit containing Reagent 1 (Buffer). It is used with the Alinity c ICT Serum Calibrator and Alinity c ICT Urine Calibrator on the Alinity c analyzer. The system utilizes ion-selective electrodes (ISE) for sodium, potassium, and chloride, which develop an electrical potential across membranes selective to each ion. This voltage is compared to calibrator voltages and converted into ion concentration. The methodology is Ion-selective electrode diluted (Indirect) and the detection is Potentiometric.

Rx. For in vitro diagnostic use only .VITROS® Chemistry Products Cl⁻ Slides quantitatively measure chloride (Cl⁻) concentration in serum, plasma, and urine using VITROS® Chemistry Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The VITROS® Chemistry Products Cl⁺ Slide assay is performed using the VITROS® Chemistry Products Cl⁺ Slide and the VITROS® Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS® Cl- Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS® Chemistry Products Cl⁺ slide. The slide consists of two ion- selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support support. The protective layer inhibits interference from normal levels of bromide and uric acid.

For in vitro diagnostic use only. VITROS Cl- DT Slides quantitatively measure chloride (CI-) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of clectrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

The VITROS Chemistry Products CI Slide assay is performed using the VITROS Chemistry Products Cl DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT Chemistry Systems. The VITROS CI DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS Chemistry Products CI DT Slide. The slide consists of two ionselective electrodes, each containing a protective laver, a silver laver and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid VITROS Chemistry Products CI DT Slides use ion-selective electrodes for potentiometric measurements of ionic chloride. Ionic chloride determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products CT DT Slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge. The chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium. Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference poised between the two electrodes is proportional to the chloride concentration in the sample. The test result is reported in millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from boyine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS DT Systems and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

The AutoDELFIA® Neonatal IRT L kit is intended for the quantitative determination of human immunoreactive trypsin (ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Standards, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium -labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is the measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.

The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes. Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma. Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases. Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis. The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.

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The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.

The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. The ion-selective electrode is using undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode.

The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface. The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.

The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Nat, K+, and Cli for the Olympus® AU Clinical Chemistry Systems. The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cl in serum by ISE. The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na * and Cl in serum samples on the Olympus® AU Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Na , K+ and Cli Electrodes on the Olympus® AU ISE systems.

The products encompassed by this 510 (k) submission are Class I (75JJG) and Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Olympus® Diagnostics. Listed below are pHoenix products and their Olympus® Diagnostics equivalents. | pHoenix<br>Cat.# | Olympus<br>Cat. # | Description | Models | Class | |------------------|-------------------|---------------------------------|--------|-------| | TBD | AUH1011 | ISE Buffer | AU | 1 | | TBD | AUH1017 | ISE Internal Reference Solution | AU | 1 | | TBD | AUH1014 | ISE Low Standard | AU | 2 | | TBD | AUH1015 | ISE High Standard | AU | 2 | pHoenix uses a similar composition, description and packaging design as that used by Olympus® Diagnostics in its products.

The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems. The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.

pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system.