Preparing for the 2018-2019 Respiratory Season

FDA Reclassification of Rapid Influenza Flu kits (RIDTs)

Frequently asked questions regarding the FDA Class II requirements include:

Yes. Upon review of new clinical trial data, on February 13, 2018, the FDA informed Quidel that the QuickVue Differentiated Influenza Test, Quidel #20183, met Class II requirements. Quidel was able to resume the manufacture and sale this product in the market.

SAN DIEGO, February 13, 2018 (Business Wire) - Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Quidel’s CLIA Waived QuickVue® Influenza A+B assay for the rapid, differential detection of Influenza types A and B.

In a recent clinical study, Quidel’s QuickVue® Influenza A+B test was shown to meet the FDA’s reclassification criteria for Class II Rapid Influenza Diagnostic Tests and is available for sale in the United States.

Yes – effective June 18, 2018, in cooperation with the FDA, Abbot Rapid Diagnostics (formerly Alere) ceased the distribution of Alere™ Influenza A&B Test – #412-000 (Test Product) and have requested their distribution partners do the same while they complete the clinical study described below. Alere has confirmed with FDA that healthcare providers can continue to use any Test Product that is currently in provider facilities.

FDA’s new requirements related to the reclassification of antigen-based rapid influenza detection test systems (RIDTs) took effect on January 12, 2018, at which time RIDTs were required to comply with new special controls (described in 21 CFR § 866.3328), including certain new minimum clinical performance criteria.  Alere Scarborough, Inc. (Alere) has been communicating with FDA about the Test Product, and has continued to distribute the Test Product while evaluating the assay under the new minimum clinical performance criteria.

The clinical study conducted during the 2008-2009 respiratory season to support CLIA waiver for the Test Product included both prospectively collected nasal swab specimens and testing swab samples prepared with archived respiratory specimens. The performance assessment based on these data meets FDA’s new minimum clinical performance criteria. However, FDA subsequently informed Abbot Rapid Diagnostics (formerly Alere) that assessments of product performance relative to the new minimum clinical performance criteria should be conducted using only prospectively collected samples. Abbott Rapid Diagnostics is conducting a clinical study using only prospectively collected samples but have agreed, in consultation with FDA, to suspend distribution of the Test Product in the United States until we complete the study.

 

Although Abbott has advised distributors to return the product for refunds, customers may continue using non-expired kits still in their inventory.

Customers may continue using such non-expired kits still in their inventory.

For all RIDTs that are marketed after January 2018, manufacturers must test against influenza viral panels provided by the Centers for Disease Control and Prevention (CDC). Both the CDC and FDA will identify the strains that must be tested based on those selected by the World Health Organization (WHO) that will comprise the annual flu vaccine. Each manufacturer must identify the tested strains in a separate section of the RIDT's Instructions for Use (IFU) and on the product website.


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