APAS Independence gets FDA clearance

Create PDF

September 2019—Clever Culture Systems announced FDA 510(k) clearance of its APAS Independence instrument and associated urine analysis module as a class II medical device.

The APAS Independence automatically screens, interprets, and sorts culture plates and can process more than 200 culture plates at a time. The instrument sorts culture plates showing significant bacterial growth from those that do not, without the need for further microbiologist assistance, the company says.