Careside Submits Hemoglobin Test for FDA Clearance.Business Editors & Health/Medical Writers CULVER CITY, Calif.--(BW HealthWire)--June 6, 2000 Careside Inc. (AMEX AMEX See: American Stock Exchange :CSA (1) (Canadian Standards Association, Toronto, Ontario, www.csa.ca) A standards-defining organization founded in 1919. It is involved in many industries, including electronics, communications and information technology. , CSA.W) announced today submission of its Careside(TM) hemoglobin blood test to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Careside also submitted a related hematocrit Hematocrit Definition The hematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anemia. Purpose Blood is made up of red and white blood cells, and plasma. test for clearance, which would be calculated from the measured hemoglobin test result. Upon FDA clearance of hemoglobin, together with the company's glucose test that is already available, the Careside Analyzer(TM) will provide the two tests most frequently ordered in a point of care setting. The Careside Analyzer is the only point-of-care instrument on the market to offer a broad test menu, which encompasses 38 FDA-cleared or exempt tests in the categories of chemistry, electrochemistry electrochemistry, science dealing with the relationship between electricity and chemical changes. Of principal interest are the reactions that take place between electrodes and the electrolytes in electric and electrolytic cells (see electrolysis), as well as the and coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or . (The company anticipates adding immunochemistry ImmunochemistryA discipline concerned both with the structure of antibody (immunoglobulin) molecules and with their ability to bind an apparently limitless number of diverse chemical structures (antigens); with the structure, organization, and rearrangement tests late this year). The compact, desktop Careside Analyzer provides clinicians with accurate, cost-effective results in just 4 to 12 minutes, much more quickly than typical results delivered by a hospital or reference laboratory. The instrument's test menu encompasses the majority of tests ordered by clinicians. FDA clearance of the hemoglobin and hematocrit tests will increase the Careside Analyzer's test menu to 40. The newly submitted hemoglobin test gives a quantitative measure of the hemoglobin concentration in an anti-coagulated whole blood sample. A sufficient concentration of hemoglobin in blood is essential for adequate transport of oxygen and carbon dioxide between lungs and other tissues. Measurement of the hemoglobin concentration is important as an initial step in the detection of anemia (diminished hemoglobin concentration) or erythrocytosis (increased red blood cell count red blood cell count, n the number of red blood cells (erthrocytes) in 1 mm3 of blood; a useful diagnostic tool in the determination of several kinds of anemia. See also mean corpuscular hemoglobin. and hemoglobin concentration). The company expects the hemoglobin and hematocrit tests to be cleared by the FDA in mid-2000. Careside has been averaging 60 days for test clearance from the date of submission. Nevertheless, the FDA can take 90 days to initially respond. Actual clearance may take longer. Safe Harbor: Statements in this press release regarding Careside Inc. which are not historical facts are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include the date of FDA clearance for hemoglobin and the availability of immunochemistry tests. Key factors that may impact on these statements include technological hurdles, FDA approval process, and other challenges inherent in product research, development, manufacturing, marketing, and other factors discussed in the company's prospectus. The company undertakes no obligation to update forward-looking statements. Please see the risk factors listed from time to time in the company's prospectus and reports on file with the SEC. |
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