FDA has granted premarket notification (510(k)) clearance to the APAS Independence instrument and associated urinalysis module, Urine AM, from Clever Culture Systems, Zurich, Switzerland.
Based on the company’s proprietary automated plate assessment system (APAS) technology, the APAS Independence is the first instrument authorized for sale in the US market to automate the reading, screening, interpretation, and sorting of microbiology culture plates. The instrument can process more than 200 culture plates at a time, responding to the growing demand of busy microbiology laboratories and the fast-growing automated pathology market.
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 enabled it to be classified as a Class II medical device.
“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,” says Peter Bradley, general manager of Clever Culture Systems.
Bradley adds that FDA clearance catalyzes the commercial launch of the instrument in the United States, with a significant number of laboratories already expressing interest, as urine specimens make up more than 50% of all specimen types processed.
“The response from the US market has been positive, and we expect rollout of the APAS Independence to targeted customers to commence before the end of 2019,” says Bradley. “The US market represents the single largest pathology market in the world, with more than 5,000 clinical laboratories. The APAS Independence is the only FDA-cleared Class II commercial product of its kind available for sale in the United States. This exciting achievement secures our first mover advantage. We will now ramp up our commercialization activities.”
For further information, visit Clever Culture Systems.