NEW YORK – Clever Culture Systems announced on Friday that its APAS Independence platform for bacterial culture analysis has received 510(k) clearance from the US Food and Drug Administration for use with methicillin-resistant Staphylococcus aureus samples.
The APAS Independence automates the screening, sorting, and interpretation of culture plates and auto-verifies negative culture plates, processing 200 plates an hour. It differentiates between culture plates with significant bacterial growth needing further review by a microbiologist and those with no significant growth.
The platform received clearance as a Class II medical device, the Bäch, Switzerland-based company said in a statement. It has also received CE marking, CCS noted.
It is now available for use with both urine and MRSA analysis modules. CCS received 510(k) clearance for the instrument with the urine analysis module in 2019.
The company signed a US distribution deal with Thermo Fisher Scientific earlier this month.
The instrument uses Automated Plate Assessment System imaging technology and artificial intelligence algorithms to sort and interpret culture plates. In an evaluation performed by Johns Hopkins Hospital, the platform successfully identified all positive MRSA samples, including three missed by microbiologists.