Studybox Research 510(k) Clinical Studies

COVID-19 Rapid Antigen Test

Clinical and analytical performance to support substantial equivalence.

Studybox

510(k) Clinical Studies

SARS-CoV-2 antigen tests entered the market under Emergency Use Authorization, and sponsors are now moving them to traditional marketing authorization as EUAs are transitioned. The clinical evidence expectations carried over from the EUA templates: prospective enrollment of symptomatic subjects early in illness, a paired high-sensitivity molecular comparator, and reporting of comparator cycle threshold values so that reviewers can see whether the antigen test's sensitivity depends on the viral load distribution of the enrolled population.

Enrollment is harder than it was. Prevalence is lower and less predictable, most positives come from people with prior infection or vaccination who carry lower viral loads, and widespread home testing means many symptomatic people never present to a clinic. Studies now typically run across multiple waves and many sites, and home-use versions add lay user studies in which untrained consumers collect, run and interpret the test without assistance.

Analyte: SARS-CoV-2 nucleocapsid antigen
Therapeutic area: Infectious Disease
Specimens: Anterior Nares (Nasal) Swab, Nasopharyngeal (NP) Swab
Intended-use settings: urgent care, physician office, pharmacy, home use, hospital POC, emergency department
Operators: Non-laboratory clinic staff in waived settings; lay users self-testing, or testing a child, for over-the-counter claims.
Comparator: Typically a high-sensitivity FDA-authorized or cleared SARS-CoV-2 RT-PCR assay on a paired swab, with the comparator's cycle threshold values recorded for each positive.

510(k) Studies specifics

What Changes for This Assay on This Pathway.

Premarket review for non-EUA SARS-CoV-2 antigen tests follows the precedent set by the first traditional authorizations; the protocol should mirror the EUA template design (prospective, symptomatic, molecular comparator with cycle thresholds) because that is the design the review division has already accepted.
A claimed symptom-onset window is a labeling commitment; subjects enrolled outside it are typically excluded from the primary analysis, so eligibility criteria and the claim must match.
Serial-testing claims for asymptomatic use require a separate design with repeated testing over several days rather than a single paired comparison.

Endpoints the study must support

Positive and negative percent agreement against the molecular comparator in symptomatic subjects within the claimed window after symptom onset, with 95% confidence intervals
Performance by days since symptom onset and by comparator cycle threshold distribution, to show that positives were not skewed toward high viral loads
For serial-testing or asymptomatic claims, agreement across a defined repeat-testing schedule
For home-use claims, lay user agreement with the comparator and labeling comprehension

Enrollment realities

Sample size is driven by the number of molecular-positive symptomatic subjects within the claimed window; with lower and unpredictable prevalence, enrollment typically runs across several months and many sites, and sponsors should plan for a wave-dependent accrual rate rather than a steady one. Not strictly seasonal; circulation rises in winter and in periodic variant-driven waves, so enrollment is planned around surveillance data rather than a calendar season.

How Studybox runs it

Pre-Qualified Sites, Embedded Coordinators.

Our 100+ pre-qualified U.S. sites are matched to the intended-use population and setting, with Studybox coordinators embedded on site for recruitment, consent, specimen handling, and data capture. Typical activation is about four weeks. How we run 510(k) clinical studies →

Same assay, other pathways

Relevant FDA guidance

Our track record here

Studies Our Team Has Run for This Test Type.

510(k), OTC lay-user · Infectious disease

510(k) Clinical Study for an Over-the-Counter COVID-19 Antigen Home Test

A visually read lateral flow test for SARS-CoV-2 nucleocapsid antigen in anterior nasal swabs received 510(k) clearance for non-prescription home use by lay users. In a prospective multisite study at about 10 sites, with about 650 symptomatic subjects who self-sampled and self-tested in a simulated home setting, the test showed about 97% PPA and about 98% NPA against a highly sensitive RT-PCR comparator.

FAQ

COVID-19 Rapid Antigen Test Study Questions.

01 Who operates the covid-19 rapid antigen test in a 510(k) studies study?

Non-laboratory clinic staff in waived settings; lay users self-testing, or testing a child, for over-the-counter claims.

02 What is the comparator for a covid-19 rapid antigen test study?

Typically a high-sensitivity FDA-authorized or cleared SARS-CoV-2 RT-PCR assay on a paired swab, with the comparator's cycle threshold values recorded for each positive.

03 What drives enrollment for a covid-19 rapid antigen test study?

Let's talk IVD research

Planning a covid-19 rapid antigen test study?

Tell us the intended use and setting. We'll come back with a site plan, operator strategy, and a realistic activation timeline for the 510(k) studies pathway.