FDA has granted premarket notification (510(k)) clearance to Applied BioCode, Santa Fe Springs, Calif, for use of the BioCode respiratory pathogen panel on the company’s MDx-3000 system.
The BioCode respiratory pathogen panel tests nasopharyngeal swabs for the most common respiratory viruses and bacteria, including adenovirus; Bordetella pertussis; Chlamydia pneumoniae; coronavirus (229E, OC43, HKU1, and NL63); human metapneumovirus A/B; influenza A and subtypes 2009pdm, H1, H1N1, and H3; influenza B; Mycoplasma pneumoniae; parainfluenza virus types 1, 2, 3, and 4; respiratory syncytial virus A/B; and rhinovirus/enterovirus.
The MDx-3000 offers ‘flexible ordering’ and ‘flexible reporting’ capabilities to address variation in test ordering patterns and potential changes in reimbursement. Designed for moderate- to high-volume laboratories, the walkaway MDx-3000 system can perform tests on up to 188 samples in an 8-hour shift. The MDx-3000 also offers a user-defined mode that enables laboratories to develop their own multiplex assays.
In addition to the respiratory pathogen panel, the company also offers the FDA-cleared 17-target BioCode gastrointestinal pathogen panel. The MDx-3000 system permits users to run both the gastrointestinal and respiratory panels at the same time.
For more information, visit Applied BioCode.
Featured image: Photo © Sachkos, courtesy Dreamstime (ID 154404596).
