Studybox Research 510(k) Clinical Studies
H. pylori Stool Antigen Test
Clinical and analytical performance to support substantial equivalence.
Studybox
510(k) Clinical Studies
Stool antigen testing detects active H. pylori infection, unlike serology, which remains positive after eradication, and the clinical study is built around that distinction. Subjects are classified as infected or not by biopsy-based methods at endoscopy or by urea breath test, and recent use of proton pump inhibitors, bismuth or antibiotics suppresses bacterial load and lowers stool antigen sensitivity, so a washout period is a standard eligibility criterion that removes a meaningful share of candidates.
A test-of-eradication claim adds a second visit several weeks after completion of therapy, which is unusual in IVD studies and introduces retention risk. Enrollment typically centers on gastroenterology and endoscopy practices with the reference method on hand, while waived-setting data for the device itself come from primary care and urgent care staff running the test on stool returned by patients.
- Analyte
- Helicobacter pylori antigen in stool
- Therapeutic area
- Gastrointestinal Health
- Specimens
- Stool
- Intended-use settings
- physician office, urgent care, hospital POC
- Operators
- Non-laboratory clinic staff in waived settings; laboratory staff for moderate-complexity claims.
- Comparator
- Typically a composite reference of biopsy-based methods (histology and rapid urease test, with or without culture) obtained at endoscopy, or urea breath test where endoscopy is not performed; the protocol defines how a subject is classified as infected.
510(k) Studies specifics
What Changes for This Assay on This Pathway.
- The composite reference must be pre-specified (how many biopsy methods, how urea breath test is weighted, how a single discordant is classified), and endoscopy-based and breath-test-based subjects are typically reported separately.
- Medication washout (proton pump inhibitors, antibiotics, bismuth) before specimen collection is an eligibility criterion that should match the labeling limitation.
- Test-of-eradication claims require a post-treatment cohort tested at a defined interval with the reference repeated, and are often a separate study.
Endpoints the study must support
- Sensitivity and specificity against the composite reference for active infection, with 95% confidence intervals
- For a test-of-eradication claim, performance at a defined interval after completion of therapy against the same reference
- Invalid rate and inter-operator agreement for visually read devices in waived settings
Enrollment realities
Driven by infected subjects with an adequate reference, which depends on access to endoscopy or breath testing; medication washout exclusions and stool return compliance are predictable losses. U.S. prevalence is modest, so site selection targets referral populations.
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
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
- Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
FAQ
H. pylori Stool Antigen Test Study Questions.
01 Who operates the h. pylori stool antigen test in a 510(k) studies study?
Non-laboratory clinic staff in waived settings; laboratory staff for moderate-complexity claims.
02 What is the comparator for a h. pylori stool antigen test study?
Typically a composite reference of biopsy-based methods (histology and rapid urease test, with or without culture) obtained at endoscopy, or urea breath test where endoscopy is not performed; the protocol defines how a subject is classified as infected.
03 What drives enrollment for a h. pylori stool antigen test study?
Driven by infected subjects with an adequate reference, which depends on access to endoscopy or breath testing; medication washout exclusions and stool return compliance are predictable losses. U.S. prevalence is modest, so site selection targets referral populations.
Let's talk IVD research
Planning a h. pylori stool antigen 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.