Studybox Research Dual Submission Studies
Point-of-Care Complete Blood Count
One integrated study supporting both 510(k) clearance and CLIA waiver.
Studybox
Dual Submission Studies
A complete blood count is many tests in one, and a point-of-care CBC study is correspondingly a set of parallel method comparisons, one per parameter, against a laboratory hematology analyzer. The first waived CBC analyzer established the model: a restricted intended use, a limited set of reported parameters with defined reportable ranges, and a flagging system that directs any result outside those ranges or suggestive of abnormality to laboratory testing rather than reporting a number. The clinical study has to show both that the numbers are accurate in the reportable range and that the flags fire when they should.
Enrollment therefore needs two kinds of subjects: people with normal results, who confirm accuracy where most results fall, and people with abnormal results, who exercise the flagging. The latter come from oncology, hematology, infectious disease and pediatric populations and must be recruited deliberately, because a healthy walk-in population will not test the low end of the platelet or white cell range.
- Analyte
- White blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, red cell indices and, where claimed, white blood cell differential
- Therapeutic area
- Hematology
- Specimens
- Venous Whole Blood, Capillary Fingerstick Blood
- Intended-use settings
- physician office, urgent care, hospital POC, emergency department
- Operators
- Medical assistants and nurses in physician offices and urgent care centers for waived versions; laboratory and point-of-care staff for moderate-complexity versions.
- Comparator
- Typically a laboratory hematology analyzer with documented calibration, with a manual microscopic differential as the reference for white cell differential parameters where claimed.
Dual Submission specifics
What Changes for This Assay on This Pathway.
- A single study at waived sites, with venous (device and comparator) and, if claimed, fingerstick (device) specimens from each subject, supports both components across all parameters.
- Abnormal specimens are typically recruited from specialty clinics within the waived-setting footprint or supplemented with a separately reported arm, because flagging performance depends on them.
- Pre-submission agreement on the parameter list, reportable ranges and flagging logic is typical before the dual study starts, since those decisions define the study.
Endpoints the study must support
- Method comparison for each reported parameter against the laboratory analyzer across its measuring range, with bias at clinical decision thresholds
- Imprecision for each parameter at low, normal and high levels, including by untrained operators at waived sites
- Flagging agreement: the device's identification of results outside its reportable range or requiring laboratory follow-up, compared with the laboratory result
- Agreement of capillary fingerstick with venous results on the device
Enrollment realities
Driven by coverage of each parameter's range and by the number of abnormal results needed to evaluate flagging; this typically requires specialty clinic recruitment and makes CBC studies larger and longer than single-analyte hematology studies.
How Studybox runs it
Pre-Qualified Sites, Embedded Coordinators.
Waiver evidence depends on genuine intended-use operators in genuine waived settings. Our network of 100+ pre-qualified urgent care, physician office, and point-of-care sites already runs IVD protocols, so operator recruitment and site activation don't start from zero. How we run dual submission studies →
Same assay, other pathways
Relevant FDA guidance
- Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
- Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
FAQ
Point-of-Care Complete Blood Count Study Questions.
01 Who operates the point-of-care complete blood count in a dual submission study?
Medical assistants and nurses in physician offices and urgent care centers for waived versions; laboratory and point-of-care staff for moderate-complexity versions.
02 What is the comparator for a point-of-care complete blood count study?
Typically a laboratory hematology analyzer with documented calibration, with a manual microscopic differential as the reference for white cell differential parameters where claimed.
03 What drives enrollment for a point-of-care complete blood count study?
Driven by coverage of each parameter's range and by the number of abnormal results needed to evaluate flagging; this typically requires specialty clinic recruitment and makes CBC studies larger and longer than single-analyte hematology studies.
Let's talk IVD research
Planning a point-of-care complete blood count 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 dual submission pathway.