Quidel and Life Technologies gain FDA clearance for assay and PCR instruments

March 21, 2013

Quidel Corp. and Life Technologies Corp. have received 510(k) clearances from the U.S. Food and Drug Administration (FDA) to market the Quidel Molecular Direct C. difficile Assay with Life Technologies’ QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-time PCR Instruments.

This Quidel Molecular Direct C. difficile Assay is part of the company’s expanding line of molecular diagnostics products. The product line offers PCR reagent kits for use by molecular diagnostic laboratories, including the QuantStudio Dx and 7500 Fast Dx. These kits provide features that include refrigerated storage instead of freezing, ready-to-use reagents, and short time-to-result. The kits include an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation. This direct-to-amplification procedure allows the assay to generate a result in less than 70 minutes.

The QuantStudio Dx Real-Time PCR instrument’s touch screen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface are designed for ease of use, and the six-color feature allows for a multiplex of six targets in one reaction. The QuantStudio Dx enables flexibility via an optional Test Development mode, allowing the use of interchangeable thermal cycling blocks that accommodate 96- or 384-well plates and a proprietary qPCR microfluidics card.

The 7500 Fast Dx Real-time PCR instrument system is a five-color instrument that delivers the performance required for high-quality results in a 96-well format. The 7500 Fast Dx is also FDA cleared for diagnostic use with the Center for Disease Control and Prevention’s H1N1 assay and with the Quidel Molecular assays for Influenza A+B and human metapneumovirus (hMPV). Learn more about Real-Time PCR instruments from Life Technologies and Quidel Molecular Direct C. difficile.