Resources for the Flu Testing Platforms

Frequently asked questions

FDA Reclassification of Rapid Influenza Flu kits (RIDTs)

FDA Reclassification

The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.

In June 2013, the FDA proposed the reclassification of Rapid Influenza Diagnostic Tests (RIDTs) from Class I to Class II. (a product has a Class II classification meaning that it has “special controls” which for Flu kits means they must meet minimum performance standards in detecting a Flu A and Flu B virus).  The FDA placed notice of this proposed change in the Federal Register on May 22, 2014 and received public commentary. This proposed change was driven by CDC concerns about the performance of these rapid influenza detection tests during the 2009 pandemic flu season.

The FDA published the final order in the Federal Register on January 12, 2017.

The goal of the reclassification is to improve performance of these test kits as compared to a reference method (viral culture or nucleic acid-based) as well as testing of annually forecasted circulating strains. The new guidelines and controls have been created to reduce the percentage of false positive results which will help drive antibiotic stewardship across the continuum of care.

Here are some of the frequently asked questions and important dates to be aware of:

The special controls identified in the FDA’s reclassification order are effective 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 standards before marketing their changed or new devices. Following a one-year transition period, FDA will begin enforcing compliance on January 12, 2018.

For all tests that meet the new criteria (existing and those that come to market post 1/12/17) manufacturers will need to test against influenza viral panels the CDC will provide (first set to be available ~ April, 2017).  Strains to be tested will be identified by the FDA in consultation with the CDC and they are anticipated to be largely based on the strains selected by WHO for the annual vaccine.

  • These will be provided free to all flu kit manufacturers
  • Manufacturer results must be ready by July 31, 2017 for this first round
  • Manufacturer will be required to include in a separate section of their PI or post on their website with a clear link for customers/potential customers to review and they must keep 3 years of data on their site
  • Manufacturer will be able to provide lowest concentration of detection of the virus
  • If not able to detect a strain on the CDC test panel, manufacturer is required to include this limitation in their package insert!

Customers can continue to purchase a flu kit that will not meet the new FDA reclassification guidelines until January 12, 2018.

A customer can continue to use a rapid influenza test kit that does not meet the new FDA guidelines until the kit expiration date .

Manufacturers can continue to manufacture and sell rapid flu kits that do not meet the new guidelines until January 12, 2018 . Distributors , viewed by the FDA as an extension of the manufacturer, can also only sell a rapid influenza detection kit that does not meet the new guidelines until January 12, 2018 .

Still trying to get the facts about the FDA reclassification of Rapid Influenza Tests (RIDTs)?

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