Studybox Research 510(k) Clinical Studies
Fecal Immunochemical Test (FIT)
Clinical and analytical performance to support substantial equivalence.
Studybox
510(k) Clinical Studies
Fecal immunochemical tests detect human hemoglobin and replaced guaiac tests because they do not react with dietary heme and are more sensitive for lower gastrointestinal bleeding. Most FIT 510(k)s have been cleared with a general intended use, detection of fecal occult blood as an aid in the diagnosis of lower gastrointestinal disorders, supported by agreement with a predicate FIT, while a colorectal cancer screening claim requires comparison to colonoscopy in a screening population, which is a far larger undertaking.
The specimen is the design problem. Patients sample their own stool with a probe into a buffered collection device, hemoglobin degrades over time and at warm temperatures, and the quantity sampled varies with technique. Stability studies and clear instructions carry much of the submission, and a qualitative FIT read by clinic staff or by a consumer at home adds operator and lay user questions on top of the specimen questions.
- Analyte
- Human hemoglobin in stool
- Therapeutic area
- Gastrointestinal Health
- Specimens
- Stool
- Intended-use settings
- physician office, home use, pharmacy, urgent care
- Operators
- Patients collect at home; non-laboratory staff in physician offices and pharmacies read qualitative devices; lay users read over-the-counter versions.
- Comparator
- Typically an FDA-cleared fecal immunochemical test as predicate for agreement studies; for a colorectal cancer screening claim, colonoscopy findings (cancer and advanced adenoma) as the clinical reference.
510(k) Studies specifics
What Changes for This Assay on This Pathway.
- An agreement study against a cleared predicate FIT on patient-collected specimens, with both devices sampled from the same stool, is the typical design for a general detection claim; the analytical cutoff in hemoglobin concentration is a labeling element.
- A colorectal cancer screening claim requires a prospective screening-population study with colonoscopy as the reference and is typically preceded by a pre-submission.
- Hemoglobin stability in the collection buffer across the labeled transport window and temperatures is a required analytical study because home collection to testing can span days.
Endpoints the study must support
- Positive and negative percent agreement with the predicate FIT on patient-collected stool, with 95% confidence intervals
- For screening claims, sensitivity and specificity for colorectal cancer and advanced neoplasia against colonoscopy
- Hemoglobin stability in the collection device across the labeled time and temperature range
- Lay user collection success and interpretation for home-use and self-collection claims
Enrollment realities
Driven by FIT-positive subjects, who are a small fraction of average-risk adults; recruitment from gastroenterology and referral populations supplements screening volume. Collection compliance and return-time failures are predictable losses.
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
- 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
- Design Considerations for Devices Intended for Home Use
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
FAQ
Fecal Immunochemical Test (FIT) Study Questions.
01 Who operates the fecal immunochemical test (fit) in a 510(k) studies study?
Patients collect at home; non-laboratory staff in physician offices and pharmacies read qualitative devices; lay users read over-the-counter versions.
02 What is the comparator for a fecal immunochemical test (fit) study?
Typically an FDA-cleared fecal immunochemical test as predicate for agreement studies; for a colorectal cancer screening claim, colonoscopy findings (cancer and advanced adenoma) as the clinical reference.
03 What drives enrollment for a fecal immunochemical test (fit) study?
Driven by FIT-positive subjects, who are a small fraction of average-risk adults; recruitment from gastroenterology and referral populations supplements screening volume. Collection compliance and return-time failures are predictable losses.
Let's talk IVD research
Planning a fecal immunochemical test (fit) 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.