It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2

March 17, 2023By Richard A. Lewis, Senior Regulatory Device & Biologics Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert

On March 8th FDA granted Quidel’s De Novo for the Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set.  This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2.  The authorization of this De Novo, with a formal classification of Class II, now opens the door for follow-up 510(k) submissions that declare this product as their predicate.

This device is indicated for the following use:

for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.

The inclusion of a requirement to test twice over three days with at least 48 hours between tests is consistent with study findings from the National Institute of Health published in 2022 (LINK); however, it is not clear if this proposed use case is practical for “point-of-care” outside of an in-patient setting.  While serial testing may be required to meet FDA’s performance bar, one can likely rely on working Americans not returning to their doctor’s office after 48 hours for the serial test.

The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.”

We note the unique use of the word “simple” to define a point-of-care device.  We are not aware of any other microbiological in vitro diagnostic test that contains the word “simple” in the regulation.

Fortunately, “simple point-of-care” is defined in the reclassification order:

A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19. The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.

Thus, ironically the definition of “simple” is anything but and is almost certain to lead to debates about what, exactly, is simple.  Moreover, it appears that the specificity of the regulation coupled with the definition of simple may limit the devices that can claim this product as a predicate to Point-of-Care antigen tests with similar workflows.  However, FDA has shown considerable flexibility in expanding the scope of de novo classifications, so it remains to be seen whether this class will, in fact, be narrowly circumscribed.

We also note that this review took place over nine (9) months and was originally submitted to FDA as a 510(k) that was given a “Not Substantially Equivalent” decision and then converted to a “De Novo.”  We are aware through public statements that companies have been pursuing traditional marketing authorizations since at least late 2021.  We take the pace and timing of this first through-the-gate submission to be a reaffirmation of the persistent stress and workload that has plagued OHT-7 and more specifically the OHT-7 COVID Team for over three years.

What does this de novo say about FDA’s expectations for data to support 510(k)s?  A lot.  In the best tradition of teasers, keep reading our blog.  HPM will provide an analysis of the special controls and decision summary in follow-up posts.

Categories: COVID19