Healthcare Industry News: blood glucose
News Release - June 27, 2006
GlucoTec, Inc. Receives FDA Clearance to Market GLUCOMMANDER(TM) PLUS Insulin Dosing SystemGREENVILLE, S.C.--(HSMN NewsFeed)--June 27, 2006--GlucoTec, Inc., (GlucoTec) based in Greenville, SC, announced today that it has received Federal Drug Administration (FDA) clearance to market Glucommander Plus ("Glucommander") as a Regulatory Class II Medical Device.
In December, 2005, GlucoTec submitted a Section 510(k) premarket notification of intent to market the Glucommander.
On June 7, 2006, GlucoTec, through its responsible third party official, Underwriter Laboratories Incorporated, received correspondence from the FDA which stated, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally market predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act."
In addition, the FDA stated Indications for Use: "The Glucommander is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, calculate and recommend a dose of saline, glucose, and insulin to drive the blood glucose level, either up or down, towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin. The device is not intended for use with patients with known insulin allergies or patients under the age of 18."
The company is currently compiling data to submit for the above non-intended indications.
About GlucoTec, Inc.
Located in Greenville, SC, GlucoTec specializes in the development, marketing, and clinical support of systems designed to manage blood glucose levels. Its initial product, Glucommander(TM), is designed to manage blood glucose levels in an acute care hospital setting. For more information, please visit www.glucotec.com
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