Sequential
510(k) first, waiver later
- Two study programs, run months apart.
- A second round of site startup and enrollment.
- Waived-setting operators recruited after the fact.
- Longer gap before the test can be sold into point of care.
Dual Submission
Clearance and Waiver, From One Study.
If your test is destined for the point of care, running the 510(k) and the CLIA waiver as separate programs means paying for site startup twice. A Dual Submission collapses them into one.
Why it saves a cycle
Two Programs, or One.
The expensive part of an IVD study is rarely the analysis. It is activating sites, contracting them, and enrolling patients. A sequential path pays that bill twice.
Dual Submission
One integrated program
- A single study design serving both submissions.
- One site activation cycle, one enrollment period.
- Intended use operators built into the design from the start.
- Clearance and waiver arrive together, ready for the POC market.
What the design has to carry
One Protocol, Both Burdens.
A Dual Submission study has to satisfy two different reviewers at once. The 510(k) side wants performance against a predicate and a comparator method. The waiver side wants proof that untrained operators in ordinary settings get the same answer, and that the device tolerates realistic misuse.
- Clinical performance in the intended use population.
- Analytical performance, precision, and reproducibility.
- Results generated by untrained intended use operators.
- Sites in genuine waived settings, not laboratories.
- Flex studies showing robustness against realistic user error.
Building all of that into one protocol from the start is what makes the pathway work. It is also why a 510(k) protocol cannot usually be converted into a Dual Submission after enrollment has begun.
Is it right for you?
A Dual Submission Usually Fits When…
- The test is intended for urgent care, physician offices, pharmacies, or similar waived settings.
- Point-of-care availability is central to the commercial plan, not a later phase.
- The device is simple enough to be run by staff without laboratory training.
- You would otherwise pursue a waiver within a year or two of clearance anyway.
If your intended use stays inside moderate or high complexity laboratories, a standard 510(k) study is the cleaner route. If you already hold clearance and need the waiver alone, see CLIA Waiver studies.
FAQ
Dual Submission Questions.
01 What is a Dual Submission?
It is FDA's pathway for seeking 510(k) clearance and a CLIA waiver together, supported by one integrated study program rather than two sequential ones. For a device intended for point-of-care use, it removes a duplicate round of study startup and enrollment.
02 Is a Dual Submission always the right choice?
No. It fits devices clearly headed for waived settings. If the intended use is limited to moderate or high complexity laboratories, a standard 510(k) is the right path. We work through that decision against your intended use and commercial plan before any protocol is written.
03 Does one study really satisfy both?
The design has to be built for it from the beginning. A Dual Submission study carries the clinical and analytical performance work a 510(k) needs while also generating data from untrained intended use operators in waived settings, plus the robustness testing a waiver requires. Retrofitting a 510(k) protocol after the fact rarely works cleanly.
04 What makes Dual Submission studies hard to staff?
They need sites that can do both jobs at once: run a rigorous protocol to submission standard, and put genuinely untrained everyday staff on the device. Most research sites offer the first without the second. Our model places trained coordinators inside ordinary clinics so both requirements are met at the same site.
05 How quickly can a Dual Submission study start?
Because our sites are pre-qualified and already contracted, activation typically takes about four weeks. The savings compound on a Dual Submission, since you avoid a second startup cycle entirely.
Let's map the pathway
Not sure whether to go dual? That's the first conversation.
Tell us the intended use and where the test needs to be sold, and we'll come back with a recommended pathway within one business day.