Studybox Research Clinical research services
IVD clinical research services, protocol to clearance
Full-service CRO execution for 510(k), CLIA waiver, dual 510(k)/CLIA waiver and EUA studies, from a team with 55+ FDA clearances. IVD only: no drug trials, one team from protocol to FDA response.
Full service
Clinical research services
What we run
510(k), CLIA waiver, dual submission and EUA studies
Every study we run is an in vitro diagnostic study. Need the sites too? They come from our own CLIA-waived study sites.
- 01
510(k) studies
Clinical and analytical performance supporting substantial equivalence.
- 02
CLIA waiver studies
Untrained intended-use operators in genuine waived settings.
- 03
Dual 510(k)/CLIA waiver
Clearance and waiver from one integrated study program.
- 04
Emergency use authorization
Clinical studies supporting an FDA emergency use authorization.
- 05
De Novo, reproducibility and precision
Also in scope when your program needs them.
Scope
What we handle and what you keep
Studybox handles
- 01Protocol design and regulatory strategy
- 02Sites, IRB and coordinators
- 03Monitoring, data and statistics
- 04Clinical study report
You keep
Your device and the final submission decisions.
Sponsor retainsWho runs it
Designed by people who have written FDA submissions
- FDA regulatory clearances
- 55+
- Studies completed
- 500+
- Years of IVD research experience
- 30+
- 9001:2015 and 20916:2019 compliant quality system
- ISO
ISO 20916 is the international standard for clinical performance studies of in vitro diagnostic devices. See the six steps of how a study runs, or meet the team.
Case studies
Recent studies
Real studies from FDA decision summaries. Sponsors stay confidential.
All case studiesNo. 01
Dual 510(k) + CLIA waiver · Infectious disease
Dual 510(k) and CLIA Waiver Study for a Reader-Based Influenza A/B Antigen Test
- What the study had to show
- Untrained operators, the nurses and medical assistants of urgent care and outpatient clinics, at about 15 CLIA-waived sites.
- Result
- Cleared and CLIA-waived: about 96% influenza A sensitivity in a single season.
No. 02
Dual 510(k) + CLIA waiver · Infectious disease
Dual 510(k) and CLIA Waiver Study for a Point-of-Care Molecular Strep A Test
- What the study had to show
- A molecular Strep A test run same-day by non-laboratory staff at 8–10 point-of-care sites, judged against culture.
- Result
- Cleared and CLIA-waived: about 96% sensitivity and 97% specificity against culture.
No. 03
Dual 510(k) + CLIA waiver · Hematology
Dual 510(k) and CLIA Waiver Study for a Point-of-Care Fingerstick PT/INR System
- What the study had to show
- Fingerstick INR run by about 10 untrained operators at 3–5 CLIA-waived sites, for a dual 510(k) and CLIA waiver.
- Result
- Cleared and CLIA-waived, with close agreement to a cleared point-of-care device (slope close to 1).
Let's talk IVD research
Start a study
Tell us the intended use, the setting and the deadline. We'll follow up within one business day.
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