The new product release, formally classified as FDA 510(k) Clearance No. K192665, features improvements in susceptibility testing performance for four important antibiotics used to treat Pseudomonas aeruginosa, as well as the addition of the combination of P. aeruginosa and aztreonam, an empiric antibiotic, to the Accelerate PhenoTest BC kit testing panel
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Accelerate Diagnostics announced that the Company has received U.S. Food and Drug Administration (FDA) clearance for a new suite of product enhancements to the Accelerate Pheno system, which improve performance and expand the system’s antimicrobial susceptibility testing (AST) menu for bloodstream infections.
The new product release, formally classified as FDA 510(k) Clearance No. K192665, features improvements in susceptibility testing performance for four important antibiotics used to treat Pseudomonas aeruginosa, as well as the addition of the combination of P. aeruginosa and aztreonam, an empiric antibiotic, to the Accelerate PhenoTest BC kit testing panel.
“These improvements to our PhenoTest BC kit will provide clinicians with an even wider array of results to inform highly tailored treatment options for patients with bacteremia and sepsis. We believe that these new tests will support improved patient outcomes and further strengthen the trust that laboratories place in our system,” commented Shelley Campeau, Accelerate’s Chief Scientific Officer.
Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, stated, “I am thrilled to offer this latest release as part of our commitment to continuous improvement of the Pheno system and to expanding upon our leadership position in rapid AST. Further to this commitment, we have multiple new products moving through our development pipeline. We expect that our next FDA filing will be for clearance of the Accelerate PhenoAST BC GN kit, our AST-only testing solution for Gram-negative bacteremia. Our entire team is dedicated to delivering these lifesaving innovations as quickly as possible to laboratories, clinicians, and patients.”
Source: Company Press Release