Studybox Research 510(k) Clinical Studies
Point-of-Care Hemoglobin Test
Clinical and analytical performance to support substantial equivalence.
Studybox
510(k) Clinical Studies
Point-of-care hemoglobin measurement is one of the oldest waived quantitative tests and serves anemia screening in primary care and pregnancy, donor eligibility at blood collection sites and bedside monitoring in hospitals. The clinical study is a method comparison against a laboratory hematology analyzer with precision studies, and its difficulty lies not in the device chemistry but in the specimen: fingerstick hemoglobin varies with technique and puncture site, and single-drop capillary results are inherently noisier than venous results.
Because the comparator runs on venous blood, the study must separate device error from capillary sampling variability. This is typically done by running the device on both the fingerstick and the venous sample from each subject, so that the device's venous result against the comparator isolates analytical bias and the fingerstick result against the venous result characterizes the sampling effect. Both are reported, and the fingerstick comparison is the one that supports the waived claim.
- Analyte
- Total hemoglobin concentration
- Therapeutic area
- Hematology
- Specimens
- Capillary Fingerstick Blood, Venous Whole Blood
- Intended-use settings
- physician office, pharmacy, urgent care, hospital POC, emergency department
- Operators
- Medical assistants, nurses, pharmacists and blood donor center staff in waived settings; laboratory staff for moderate-complexity claims.
- Comparator
- Typically a laboratory hematology analyzer with documented calibration, or the cyanmethemoglobin reference method, run on paired venous EDTA blood.
510(k) Studies specifics
What Changes for This Assay on This Pathway.
- Method comparison against a calibrated laboratory analyzer on venous blood, with specimens distributed across the range including anemic and polycythemic values, is the core of the submission.
- Interferences specific to hemoglobin photometry (lipemia, marked leukocytosis, hyperbilirubinemia, abnormal plasma proteins) are addressed analytically and in labeling.
- If the device reports additional parameters such as hematocrit or derived values, each needs its own comparison.
Endpoints the study must support
- Method comparison bias against the laboratory comparator across the measuring range, with emphasis on anemia and transfusion decision thresholds
- Imprecision at low, normal and high hemoglobin concentrations, including at waived sites by untrained operators
- Agreement of capillary fingerstick results with venous whole blood on the device and with the comparator
Enrollment realities
Driven by coverage of the hemoglobin range, particularly low values at anemia and transfusion thresholds, which prenatal, oncology or dialysis populations typically supply. Subject count is moderate, but range coverage, not count, sets completion.
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
FAQ
Point-of-Care Hemoglobin Test Study Questions.
01 Who operates the point-of-care hemoglobin test in a 510(k) studies study?
Medical assistants, nurses, pharmacists and blood donor center staff in waived settings; laboratory staff for moderate-complexity claims.
02 What is the comparator for a point-of-care hemoglobin test study?
Typically a laboratory hematology analyzer with documented calibration, or the cyanmethemoglobin reference method, run on paired venous EDTA blood.
03 What drives enrollment for a point-of-care hemoglobin test study?
Driven by coverage of the hemoglobin range, particularly low values at anemia and transfusion thresholds, which prenatal, oncology or dialysis populations typically supply. Subject count is moderate, but range coverage, not count, sets completion.
Let's talk IVD research
Planning a point-of-care hemoglobin test 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.