Cleared Dual Track

Visby Medical Sexual Health Test

K220407 · Visby Medical · Microbiology

Mar 2023

Decision

386d

Days

Class 2

Risk

About This 510(k) Submission

K220407 is an FDA 510(k) clearance for the Visby Medical Sexual Health Test, a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Visby Medical (San Jose, US). The FDA issued a Cleared decision on March 7, 2023, 386 days after receiving the submission on February 14, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K220407 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2022
Decision Date	March 07, 2023
Days to Decision	386 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QEP — Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3393
Definition	A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.