APAS® Independence Receives FDA Clearance Ready for Sale in the US
Clever Culture Systems has announced the successful 510(k) clearance of its APAS® Independence instrument and associated urine analysis module (AM) by the United States FDA.
The APAS® Independence becomes the first of its kind to automate the reading of culture-plate screening and interpretation in the United States.*
The APAS® Independence is designed with an innovative platform technology and can automatically screen, interpret and sort culture plates. It responds to the growing demands of busy laboratories and the fast-growing automated pathology market, processing more than 200 culture plates at a time.
FDA 510(k) Clearance as a Class II Medical Device
The APAS® Independence sorts culture plates showing significant bacterial growth from those that do not, without the need for further microbiologist assistance. The nature of the device as a true walkaway system requiring no further clinical intervention enables it to be classified as a Class II medical device.
Clever Culture Systems General Manager Peter Bradley said approval from the FDA was the final regulatory achievement for the APAS® instrument. “This clearance paves the way for sales of the platform with Urine AM to commence – a milestone achieved ahead of the expected clearance time, previously expected in the second half of 2019,” he said.
US Market Opportunity
Mr Bradley said FDA clearance of the APAS® Independence with Urine AM catalyses the commercial launch of the instrument in the United States. Mr Bradley said a significant number of laboratories in the US had already expressed interest in the instrument with the Urine AM, as urine specimens make up more than 50 per cent of all specimen types processed there.
“The response from the US market has been positive, and we expect roll-out of the APAS® Independence to targeted customers to commence before the end of 2019,” he said. “The US market represents the single largest pathology market in the world, with more than 5,000 clinical laboratories,” he said. “The APAS® Independence is the only FDA cleared Class II commercial product of its kind available for sale in the US. This exciting achievement secures our first mover advantage. We will now ramp up our commercialisation activities.”
ASM Microbe San Francisco
In June this year, Clever Culture Systems will present the APAS® Independence at the American Society of Microbiology (ASM) Microbe Meeting in San Francisco. This will be supported by key opinion leader Dr Glen Hansen (Hennepin Healthcare System, Minneapolis) presenting data on the topic “Intelligent automation – The first US use of the APAS® Independence delivering artificial intelligence for clinical microbiology automation” based on his laboratory’s independent evaluation of the APAS® Independence.
*Clever Culture Systems are not aware of any other competing products cleared by the FDA for similar applications, making the Independence the only available instrument that automates culture-plate screening and interpretation.
Date Published: 21st May 2019
Source article link: Clever Culture Systems
Automatically Remove Non-Significant Culture Plates