Cleared Dual Track

Visby Medical Sexual Health

K200748 · Visby Medical · Microbiology

Aug 2021

Decision

521d

Days

Class 2

Risk

About This 510(k) Submission

K200748 is an FDA 510(k) clearance for the Visby Medical Sexual Health, 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 August 26, 2021, 521 days after receiving the submission on March 23, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K200748 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2020
Decision Date	August 26, 2021
Days to Decision	521 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.