FDA Clears Clever Culture’s Automated Plate Assessment System

Clever Culture Systems AG (CCS) has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its Automated Plate Assessment System (APAS). 
 
APAS is touted by the company as a breakthrough artificial Intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation. APAS enables laboratory efficiency in addition to the faster diagnosis and reporting of infectious diseases. 
 
Developed by LBT Innovations, APAS has been licensed on a global, exclusive basis to CCS, which is integrating APAS with laboratory robotic instrumentation. CCS plans to bring APAS to market in 2017 as an automated stand-alone plate reader (APAS Independence) closely followed by the integrated incubator (APAS Incubot). 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 United States over a 12-month period. In each trial, APAS achieved its target primary endpoints and the results matched or exceeded the findings of a panel of experienced microbiologists. 
 
“Rigorous analysis by the FDA has resulted in CCS being given clearance for the manual version of the APAS instrument,” said Peter Bradley, general manager of CCS. “This is a tribute to the nature of the technology and the work of our clinical trial partners and our team of microbiologists and image analysis specialists. We believe APAS technology is going to make a significant difference to the efficiency of microbiology laboratories globally.”
 
CCS Chair Lusia Guthrie confirmed the company is continuing discussions with global diagnostics firms for the licensing of the APAS product portfolio, including APAS Independence and APAS Incubot, plus flow-on product opportunities on the drawing board all aimed at the clinical microbiology laboratory. 
 
“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,” concluded Klaus-Gϋnter Eberle, CEO and owner of Andreas Hettich GmbH.

Clever Culture Systems is a Swiss-based joint venture between Australian medical technology company LBT Innovations Ltd. and Hettich AG of Switzerland. The company is based in Australia.