Clever Culture Systems (CCS) has secured 510(k) de novo clearance from the US Food and Drug Administration (FDA) for its automated plate assessment system (APAS).
The regulator approved APAS as a class II medical device for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation.
The new system has been developed to help laboratories to rapidly diagnose and report about infectious diseases.
Developed by LBT Innovations, APAS has been licensed to CCS on a global and exclusive basis.
CCS intends to launch the APAS in the next year as an automated stand-alone plate reader (APAS Independence). Later, it will be introduced as an integrated incubator (APAS Incubot).
During a 12-month period, the 510(k) de novo submission used a manual version of APAS to test 10,000 patients in a series of clinical trials conducted in Australia and the US
According to the company, APAS achieved its target primary endpoints in each trial and the results matched or exceeded the findings of a panel of experienced microbiologists.
CCS general manager Peter Bradley said: “Rigorous analysis by the FDA has resulted in CCS being given clearance for the manual version of the APAS instrument.
“This is a tribute to the robust nature of the technology and the hard work of our clinical trial partners and our team of microbiologists and image analysis specialists.”
CCS is a joint venture between Australian medical technology company LBT Innovations and Swiss firm Hettich.
Hettich owner and CEO Klaus-G?nter Eberle said: “We are delighted by this result. This is another stepping stone to getting our APAS based instruments into microbiology laboratories and making a difference to patient outcomes.”
Image: The FDA has approved LBT’s automated plate assessment system as a class II medical device. Photo: courtesy of Clever Culture Systems.