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Decision Diagnostics' Fundamental Genchoice! Diabetic Test Strip Moves into Formal Managed Clinical Trials and Advanced Testing for Upcoming 510k Filing with U.S. FDA
Decision Diagnostics' Fundamental Genchoice! Diabetic Test Strip Moves into Formal Managed Clinical Trials and Advanced Testing for Upcoming 510k Filing with U.S. FDA.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"DECN Anticipates Initial International Sales of 165,000 Genchoice! Boxes Per Month as it also Readies Panacea Genprecis! System, and as Hybrid Private Label Plan Reaches IntensityLOS ANGELES, CA / ACCESSWIRE / March 13, 2018 / Decision Diagnostics Corp. (OTC PINK: DECN) is a manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! diabetes test strip, the new internationally launched GenSure! \"Feather\" diabetes test strip, and the clinical trial ready GenChoice! \"Ladybug\" diabetes test strip. Today, the company communicates the completion of the first stage clinical testing and the anticipated progression to IRB controlled clinical trial on March 15, 2018 for the new GenChoice! (the \"Ladybug\") diabetes test strip. Within 45 days following the conclusion of these clinical trials, a 510K application for market clearance will be filed with the U.S. FDA. Necessary documentation and justifications are currently being assembled and legal and technical expertise has been engaged. Prior to FDA market clearance, GenChoice! will be exclusively distributed to select International markets after completion of the clinical trials during the month of May 2018. Management believes that the GenChoice! combination of rich features and compelling pricing will command immediate and extensive demand within those targeted international markets.Keith Berman, CEO of Decision Diagnostics, commented, \"We have made remarkable strides with the development progression of GenChoice! This process has entailed the manufacture of 138 pre-manufacture stage lots for clinical testing, bench testing, and comparative evaluation. The results of these examinations have encouraged the revision of our manufacturing forecast for International sales to 165,000 for 50 count boxes/units per month.\"DECN's first product, GenUltimate! glucose test strips, are compatible with the market leading Johnson & Johnson's (\"J&J\") LifeScan OneTouch Ultra family of glucose testing meters. The newest products, GenSure! and GenChoice! test strips, will both now also work each with a family of predicate testing meters.Mr. Berman continued, \"DECN anticipates the GenChoice! introduction to International markets in June 2018 as a prelude to the eventu...