K200748 is an FDA 510(k) clearance for the Visby Medical Sexual Health. Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.
Submitted by Visby Medical (San Jose, US). The FDA issued a Cleared decision on August 26, 2021 after a review of 521 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.
View all Visby Medical devices
NCT04098900
Completed
Observational
Industry-sponsored
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
| Condition studied |
Chlamydial Infection; Gonococcal Infection; Trichomoniasis |
| Eligibility |
Female only
· 14 Years+
· Healthy volunteers accepted
|
| Sponsor |
Visby Medical
(industry)
|
Started 2019-09-16
→
Primary completion 2019-12-03
Primary outcome
The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP)
Secondary outcome
Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators.
Study completed - no results published.
This trial concluded in 2019 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov