Studybox Research Case studies
How the Studies Actually Ran.
Clinical studies behind FDA clearances and emergency use authorizations our team has run, at Studybox and before that as Toolbox Medical Innovations: the design, the operators and sites, and the results FDA reviewed. Sponsors are confidential.
Studybox
Case studies
Dual 510(k) + CLIA waiver
06studies
- Cleared and CLIA-waived, with close agreement to a cleared point-of-care device (slope close to 1).
Hematology
Point-of-Care Fingerstick PT/INR System
- Cleared and CLIA-waived: about 96% sensitivity and 97% specificity against culture.
Infectious disease
Point-of-Care Molecular Strep A Test
- Cleared and CLIA-waived: about 90% influenza A sensitivity across about 1,550 evaluable samples.
Infectious disease
Rapid Antigen Influenza A/B Test
- Cleared and CLIA-waived: about 96% influenza A sensitivity in a single season.
Infectious disease
Reader-Based Influenza A/B Antigen Test
- Cleared: about 90% sensitivity and 95% specificity against an FDA-cleared molecular comparator.
Infectious disease
Point-of-Care Molecular RSV Test
- Cleared: about 97% influenza A and 94% influenza B sensitivity against an FDA-cleared comparator.
Infectious disease
Point-of-Care Molecular Flu A/B Test
510(k)
03studies
- 510(k) cleared for home use: about 97% PPA and about 98% NPA across about 650 symptomatic subjects.
Infectious disease
Over-the-Counter COVID-19 Antigen Home Test
- 510(k) cleared, with WBC correlation above 0.9 across about 500 specimens.
Hematology
Point-of-Care CBC Analyzer with 5-Part Differential
- 510(k) cleared, with a slope close to 1 against the laboratory reference across about 350 subjects.
Hematology
Point-of-Care Fingerstick PT/INR System
Emergency use authorization
05studies
- Authorized for home use: about 82% PPA and 100% NPA across about 500 subjects at 5–7 U.S. sites.
Infectious disease
Over-the-Counter Home Rapid Antigen SARS-CoV-2 Test
- Authorized for home use: about 90% PPA and 97% NPA against RT-PCR.
Infectious disease
Non-Prescription Home Molecular SARS-CoV-2 Test
- Authorized: about 85% sensitivity and 100% specificity in about 100 symptomatic subjects.
Infectious disease
Point-of-Care Instrument-Read SARS-CoV-2 Antigen Test
- Authorized: about 86% SARS-CoV-2 PPA against RT-PCR on about 300 prospective swabs.
Infectious disease
Point-of-Care Instrument-Read Rapid Antigen SARS-CoV-2 and Influenza A/B Test
- Authorized for point-of-care use: about 90% PPA across about 300 evaluable specimens.
Infectious disease
Point-of-Care Molecular SARS-CoV-2 Test
Let's talk IVD research
Wherever you fit in the research process, Studybox is here to support you.
Sponsor or clinic: tell us about your study or your site and we'll follow up within one business day.