Studybox Research 510(k) Clinical Studies
COVID-19 and Influenza A/B Combination Rapid Antigen Test
Clinical and analytical performance to support substantial equivalence.
Studybox
510(k) Clinical Studies
Combination tests report three results from one swab, and the clinical study must support each independently. In practice this is three studies sharing a population: the influenza A and B analyses are held to the special controls for antigen-based influenza tests, while the SARS-CoV-2 analysis follows the expectations established for standalone SARS-CoV-2 antigen tests. A season that produces plenty of SARS-CoV-2 and influenza A but little influenza B leaves the submission incomplete.
The multi-line result window introduces a readability question that single-analyte tests do not have. Operators and lay users must correctly assign a faint line to the right analyte, and flex and human factors work typically probes this directly. Because the three viruses do not circulate on the same schedule, combination studies are routinely planned across two or more respiratory seasons.
- Analyte
- SARS-CoV-2 nucleocapsid antigen and influenza A and B nucleoprotein antigens, reported separately from one specimen
- 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 for over-the-counter versions.
- Comparator
- Typically FDA-cleared or authorized molecular assays for SARS-CoV-2 and for influenza A/B, run on a paired swab, with cycle threshold values recorded.
510(k) Studies specifics
What Changes for This Assay on This Pathway.
- Each analyte's clinical performance is evaluated against its own molecular comparator and its own acceptance expectation; the influenza components must meet the antigen-test special controls regardless of how the SARS-CoV-2 component performs.
- Co-infected subjects are typically reported in a separate table, and the protocol should specify whether a single comparator specimen is split or separate comparator assays are run.
- Analytical cross-reactivity between the analytes (an influenza-positive specimen producing a SARS-CoV-2 line and vice versa) is a specific review question for multiplexed lateral flow devices.
Endpoints the study must support
- Positive and negative percent agreement for each of the three analytes (SARS-CoV-2, influenza A, influenza B) separately, each with 95% confidence intervals
- Agreement when the comparator is positive for more than one target (co-infection), reported descriptively
- Invalid rate and, for home use, lay user interpretation of a multi-line result window
Enrollment realities
Driven by influenza B positives in most seasons, and by SARS-CoV-2 positives when a wave is absent; realistic plans assume two seasons and a large site footprint. Co-infections are too infrequent to power on and are reported descriptively. Influenza components depend on the fall-to-spring season; SARS-CoV-2 circulates year-round with winter and variant-driven peaks, so enrollment windows differ by analyte within the same study.
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
- Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
- Design Considerations for Devices Intended for Home Use
- Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
- Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
FAQ
COVID-19 and Influenza A/B Combination Rapid Antigen Test Study Questions.
01 Who operates the covid-19 and influenza a/b combination rapid antigen test in a 510(k) studies study?
Non-laboratory clinic staff in waived settings; lay users for over-the-counter versions.
02 What is the comparator for a covid-19 and influenza a/b combination rapid antigen test study?
Typically FDA-cleared or authorized molecular assays for SARS-CoV-2 and for influenza A/B, run on a paired swab, with cycle threshold values recorded.
03 What drives enrollment for a covid-19 and influenza a/b combination rapid antigen test study?
Driven by influenza B positives in most seasons, and by SARS-CoV-2 positives when a wave is absent; realistic plans assume two seasons and a large site footprint. Co-infections are too infrequent to power on and are reported descriptively. Influenza components depend on the fall-to-spring season; SARS-CoV-2 circulates year-round with winter and variant-driven peaks, so enrollment windows differ by analyte within the same study.
Let's talk IVD research
Planning a covid-19 and influenza a/b combination 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.