Studybox Research 510(k) Clinical Studies
Point-of-Care Lipid Panel
Clinical and analytical performance to support substantial equivalence.
Studybox
510(k) Clinical Studies
Point-of-care lipid testing has a long waived history and a well-defined accuracy framework: the National Cholesterol Education Program's total error goals and the CDC's reference method network give every lipid device a common yardstick. The clinical study is a method comparison for each analyte, with precision studies, and the waiver question is whether untrained operators using fingerstick blood achieve results within those goals.
Fasting status, capillary versus venous matrix and the handling of triglyceride-rich samples are the design issues. Triglycerides vary with recent meals, LDL is usually calculated and inherits error from the other analytes, and some devices cannot calculate LDL at high triglyceride concentrations. Subjects must be recruited to cover the ranges relevant to treatment decisions, including high LDL and high triglyceride values that are uncommon in a healthy walk-in population.
- Analyte
- Total cholesterol, HDL cholesterol and triglycerides, with calculated or directly measured LDL cholesterol and non-HDL cholesterol
- Therapeutic area
- Cardiovascular Disease
- Specimens
- Capillary Fingerstick Blood, Venous Whole Blood, Serum and Plasma
- Intended-use settings
- physician office, pharmacy, urgent care, hospital POC
- Operators
- Pharmacists, medical assistants and nurses in waived settings, including pharmacy and workplace screening programs.
- Comparator
- Typically a laboratory method traceable to the CDC Cholesterol Reference Method Laboratory Network (Abell-Kendall for total cholesterol; beta-quantification for HDL and LDL), or a laboratory analyzer with documented traceability to those methods.
510(k) Studies specifics
What Changes for This Assay on This Pathway.
- Each analyte needs its own method comparison and precision study against a CRMLN-traceable comparator, and LDL, if calculated, is assessed as reported by the device rather than recalculated.
- Matrix claims (fingerstick, venous whole blood, serum, plasma) are each supported, typically with the fingerstick comparison as the clinical study and laboratory matrix comparisons for the others.
- Interference from hemolysis, lipemia itself, bilirubin and common drugs such as ascorbic acid and acetaminophen is an analytical program that informs labeling.
Endpoints the study must support
- Bias and imprecision for each analyte against the traceable comparator, assessed against the established total allowable error goals for lipid testing
- Agreement of capillary fingerstick with venous whole blood and serum or plasma on the device
- Agreement in clinical classification at the treatment-decision cut points used in cholesterol guidelines
Enrollment realities
Driven by coverage of the measuring range for each analyte, especially elevated LDL and triglycerides; walk-in populations skew normal and recruitment plans typically target clinics managing dyslipidemia.
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 Lipid Panel Study Questions.
01 Who operates the point-of-care lipid panel in a 510(k) studies study?
Pharmacists, medical assistants and nurses in waived settings, including pharmacy and workplace screening programs.
02 What is the comparator for a point-of-care lipid panel study?
Typically a laboratory method traceable to the CDC Cholesterol Reference Method Laboratory Network (Abell-Kendall for total cholesterol; beta-quantification for HDL and LDL), or a laboratory analyzer with documented traceability to those methods.
03 What drives enrollment for a point-of-care lipid panel study?
Driven by coverage of the measuring range for each analyte, especially elevated LDL and triglycerides; walk-in populations skew normal and recruitment plans typically target clinics managing dyslipidemia.
Let's talk IVD research
Planning a point-of-care lipid panel 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.