Cleared Traditional

BD CTGCTV2

K243343 · Bd Integrated Diagnostic Solutions/Becton, · Microbiology

Apr 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K243343 is an FDA 510(k) clearance for the BD CTGCTV2, a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Bd Integrated Diagnostic Solutions/Becton, (Sparks, US). The FDA issued a Cleared decision on April 22, 2025, 179 days after receiving the submission on October 25, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K243343 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2024
Decision Date	April 22, 2025
Days to Decision	179 days
Submission Type	Traditional
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.