Australian medical technology company LBT Innovations (ASX:LBT) has announced that its 50 per cent owned joint venture company, Clever Culture Systems (CCS), has received 510(k) clearance from the US FDA for its APAS Independence instrument with associated urine analysis module (AM).
The company said FDA clearance is the final regulatory milestone enabling commencement of sales of the APAS Independence in the US.
"LBT is not aware of any other competing products cleared by the FDA for similar applications, making the APAS Independence the only commercially available instrument for the automatic reading of culture plates in the United States," said the company.
"The APAS Independence is a fully automated instrument with the ability to process over 200 culture plates per hour, which is at least three times faster than manual culture plate reading," it said.
"The instrument is able to differentiate culture plates showing bacterial growth from those that are not, without the need for highly skilled microbiologist assistance. This is key to the clinical utility of the instrument that enables the instrument to be truly autonomous, and without the need for further intervention."
The APAS Independence is a Class II medical device.
This second FDA clearance is an extension of that achieved in October 2016 for the manual loading version, APAS Compact.
"This FDA clearance for the APAS Independence with urine AM represents a significant step forward in CCS’s 2019 commercialisation plan as it enables commercial launch to begin in the United States," said the company.
"With over 5,000 clinical laboratories, the United States represents the single largest pathology market in the world. The Company estimates that there are more than 1,500 laboratories that exceed the daily culture plate volume that would make the commercial return on investment for the purchase of an APAS® Independence attractive.
"With this FDA clearance, CCS will now ramp up its commercial activities in the United States with sales lead generation activities having already begun. Building from the Company’s experience in the Australian market and with a better understanding of lead time for sales, CCS has already reached out to over 800 laboratory stakeholders in the United States."