FDA Clearance

12 Months Ended

Dec. 31, 2019

Research and Development [Abstract]

FDA Clearance

NOTE 4. FDA CLEARANCE

On January 1, 2017, the regulatory review process had progressed to a point that objective and persuasive evidence of approval was sufficiently probable and a future economic benefit existed. Inventory produced after that date has been capitalized, and before that date has been expensed. On February 23, 2017, the U.S. Food and Drug Administration (“FDA”) granted Accelerate’s de novo request to market the Accelerate Pheno system and Accelerate PhenoTest BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples.