Australian medical technology company LBT Innovations (ASX LBT) has announced the submission of a 510(k) application to the US FDA for the APAS Independence inclusive with the MRSA analysis module as a Class 2 medical device.
The company said the submission uses its previously cleared APAS Independence device with Urine analysis module as a predicate device.
"The submission is supported by clinical data comparing the performance of the APAS Independence against a reference panel of three clinical microbiologists across over 1,500 patients’ specimens," it said.
"This important regulatory milestone in the United States, follows the CE Mark and TGA registration gained in September 2019 which then enabled commercial access to the European Union and Australia for the MRSA analysis module."
The company said, subject to FDA clearance for the MRSA analysis module, it will have two analysis modules available for sale with its APAS Independence in the US. It said together these two analysis modules can address approximately 50-70 per cent of cultured specimens processed by the majority of laboratories in the US.
LBT CEO and managing director Brent Barnes said, “We are very pleased to submit this 510(k) application to the FDA and seek approval for our MRSA module which has already been approved in the European Union and Australian markets.
"I would like to recognise our clinical and regulatory teams for the hard work leveraging their experience from our two previous FDA submissions which have been approved. This has been a significant effort from all those involved. We believe that expanding the number of analysis modules to our customers in each region is a critical part of our commercialisation strategy for the APAS technology.
"Put simply, increasing the number of tests that can be processed on the APAS® instrument further increases the potential cost savings for our customers.”