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 On January 12, 2017, the FDA notified the public of their decision to reclassify rapid immunoassay diagnostic tests (RIDTs) from Class I into Class II devices with special controls (minimum performance standards)

WHAT DOES THAT MEAN FOR MANUFACTURERS?

Manufacturers of antigen based rapid immunoassay diagnostic tests (RIDTs) that have been legally marketing an influenza diagnostics device prior to this date, manufacturers must obtain a new 510(k) clearance and demonstrate compliance with the special controls included in the new standards.   The FDA will begin enforcing compliance on manufacturer’s beginning January 12, 2018. 

 WHAT DOES THIS MEAN TO MY PRACTICE OR LAB?

 This reclassification will impact the OSOM Influenza A&B Test (Catalog # 190), for we have decided not to pursue a new 510(k) clearance. Sekisui Diagnostics has decided to remove this product from the market on January 12, 2018.

 WHAT DO I DO?

 If you are a current user of the OSOM Influenza A&B Test you do have options.

  •  You can continue to purchase the product until January 12, 2018 and continue to utilize the product until the expiration date on the kit.
    • For example, if you have inventory which expires February 5, 2019, you can continue to use the product until February 5, 2019
    • If you would like to order more OSOM Influenza A&B product between now and January 12, 2018 please contact your distributor or Sekisui Diagnostics 800-332-1042.
  • If you would like to start using another rapid test now, we can help get you transitioned to the OSOM Ultra Flu A&B Test (Catalog #1006) Test, The OSOM Ultra Flu A&B Test does meet the new FDA classification and performance criteria defined in the final rule (21 CFR 866.3328).
  • If you would like more information on the OSOM Ultra Flu A&B Test to get started with an evaluation kit complete the form on this pageor you can contact our Technical Services Team at 800-332-1042, option #3.

OTHER RESOURCES

  • OSOM Flu and Ultra Flu Special Offier.  Hurry it ends December 31, 2017!
  • If you would like more information in regards to the FDA’s reclassification of rapid antigen influenza testing, please visit our blog click here
  • Learn more about the reclassification at the Federal Register web site click here