Applied BioCode Receives FDA 510(k) Clearance for Syndromic Respiratory Pathogen Panel

SANTA FE SPRINGS, Calif.–(BUSINESS WIRE)–Applied BioCode announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its BioCode® Respiratory Pathogen Panel (RPP) for use on the BioCode® MDx-3000 System.

The BioCode® RPP tests nasopharyngeal swabs for of the most common viruses and bacteria, including Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, Respiratory Syncytial Virus A/B, Parainfluenza virus types 1, 2, 3, and 4, Human Metapneumovirus A/B, Adenovirus, Rhinovirus/Enterovirus, Coronavirus (229E, OC43, HKU1, and NL63), Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis.

The BioCode® MDx-3000 offers “flexible ordering” and “flexible reporting” capabilities to address variation in test ordering patterns and potential changes in reimbursement. In addition to the RPP, the company also has an FDA-cleared 17-target BioCode® Gastrointestinal Pathogen Panel (GPP). The system allows users to run the RPP and GPP combo panels at the same time, providing both time and labor saving efficiencies.

The walk-away BioCode® MDx-3000 system, with the capability to process up to 188 samples in an 8-hour shift, is designed for moderate to high volume laboratories to improve lab workflow, reduce labor and cost. It is an alternative to high cost, low throughput cartridge-based molecular test systems. The BioCode® MDx-3000 also offers a User Defined Mode where laboratories can develop their own multiplex assays.