Update Regarding the Reclassification of Influenza Diagnostics
On January 12, 2017, the FDA notified the public of its decision to reclassify antigen-based rapid influenza detection test systems (RIDTs) intended to detect influenza virus directly from clinical specimens from Class I into Class II devices with special controls (minimum performance standards). Driven by CDC concerns about the performance of these systems following the influenza pandemic of 2009, the reclassification was proposed on June 12, 2013, and since then, manufacturers, including Abbott, have been working with the FDA to prepare for the new clinical performance standards.
The special controls identified in the FDA’s reclassification order are effective as of February 13, 2017. For antigen-based RIDTs that have been legally marketed prior to this date, manufacturers must obtain a new 510(k) clearance and demonstrate compliance with the special controls included in the new clinical performance standards before marketing their changed or new devices. Following a one-year transition period, FDA will begin enforcing compliance as of January 12, 2018.
What Does This Mean for Abbott Customers?
As the market leader in rapid diagnostics, Abbott is well-positioned to meet the newly updated FDA requirements and provide customers a portfolio of influenza tests to address a variety of needs:
- The molecular-based ID NOW™ (formerly Alere™ i) Influenza A & B test (CLIA-waived in January 2015) is already a Class II device and exceeds all stated requirements in the recent FDA reclassification. Customers considering changing from non-compliant RIDTs have the opportunity to switch to a highly sensitive molecular-based platform with ID NOW.
- Abbott has also received 510(k) Class II clearance and CLIA waiver of a new, second-generation RIDT card, BinaxNOW® Influenza A & B Card 2, and the new Alere™ Reader, soon to be DIGIVAL™.
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