Studybox Research 510(k) Clinical Studies

Point-of-Care Complete Blood Count

Clinical and analytical performance to support substantial equivalence.

Studybox

510(k) Clinical 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.

510(k) Studies specifics

What Changes for This Assay on This Pathway.

Each parameter needs its own method comparison and precision study; the white cell differential, if claimed, is compared to a manual differential reference as well as the analyzer.
Reportable ranges and flagging rules are labeling elements the clinical data must support, and the submission typically reports flag agreement as its own analysis.
Specimen handling (EDTA tube fill, mixing, time from draw) affects CBC parameters, and the study should document these for both device and comparator specimens.

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.

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

Our track record here

Studies Our Team Has Run for This Test Type.

510(k) · Hematology

510(k) Multi-Site Method Comparison Study for a Point-of-Care CBC Analyzer with 5-Part Differential

A cartridge-based point-of-care hematology analyzer reporting 20 CBC parameters, including a 5-part leukocyte differential, from capillary or venous K2EDTA whole blood received 510(k) clearance for clinical laboratory and point-of-care use in adults and children at least 2 years of age. Method comparison on about 500 specimens at 2–4 point-of-care sites showed agreement with a laboratory hematology analyzer for all parameters except basophils. A supplemental elevated-basophil study, WBC flagging analysis against the laboratory analyzer and blood films, and a paired capillary-venous study completed the evidence.

FAQ

Point-of-Care Complete Blood Count Study Questions.

01 Who operates the point-of-care complete blood count in a 510(k) studies 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?

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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 510(k) studies pathway.