This is a companion article to the feature, “Point-of-Care Tests Help Manage Influenza.”

1703 BD-Murray Figure 5 Reclassification infographic_170724_v4

Infographic courtesy BD. Click to expand.

As defined by the FDA reclassification order issued earlier this year, the new performance requirements for rapid influenza diagnostic tests (RIDTs) are as described below.1,2 In order to be cleared for marketing and remain on the market, the device’s sensitivity and specificity performance characteristics must meet one of the following two minimum clinical performance criteria.

If the manufacturer chooses to compare the device to viral culture:

  • The sensitivity estimate for the device when testing for influenza A must be at least at the 90% point estimate, with a lower bound of the 95% confidence interval that is greater than or equal to 80%. The sensitivity estimate for the device when testing for influenza B must be at least at the 80% point estimate, with a lower bound of the 95% confidence interval that is greater than or equal to 70%.
  • The specificity estimate for the device when testing for influenza A and influenza B must be at least at the 95% point estimate, with a lower bound of the 95% confidence interval that is greater than or equal to 90%.

If the manufacturer chooses to compare the device to an appropriate molecular comparator method:

  • The positive percent agreement for the device when testing for influenza A and influenza B must be at least at the 80% point estimate, with a lower bound of the 95% confidence interval that is greater than or equal to 70%.
  • The negative percent agreement for the device when testing for influenza A and influenza B must be at least at the 95% point estimate, with a lower bound of the 95% confidence interval that is greater than or equal to 90%.

Enforcement of the reclassification order begins January 12, 2018, except in the following cases.

  • Manufacturers of antigen-based RIDTs not legally marketed prior to February 13, 2017, must obtain FDA premarket notification (510(k)) clearance by this date.
  • Manufacturers of antigen-based RIDTs legally marketed prior to February 13, 2017, but required to submit 510(k) due to significant modifications must obtain 510(k) clearance by this date.

References

  1. Jackson M, Chung J, Jackson L, et al. Influenza vaccine effectiveness in the United States during the 2015–2016 season. N Engl J Med. 2017;377(6):534–543; doi: 10.1056/nejmoa1700153.
  1. Microbiology devices; reclassification of influenza virus antigen detection test systems intended for use directly with clinical specimens [final rule]. 82 Federal Register 8 (January 12, 2017):3609–3619. Available at: www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for. Accessed August 8, 2017.