Cleared Traditional

eNAT molecular collection and preservation medium

K201849 · Copan Italia Spa · Microbiology

Sep 2020

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K201849 is an FDA 510(k) clearance for the eNAT molecular collection and preservation medium, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Copan Italia Spa (Brescia, IT). The FDA issued a Cleared decision on September 17, 2020, 73 days after receiving the submission on July 6, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K201849 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2020
Decision Date	September 17, 2020
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QBD — Microbial Nucleic Acid Storage And Stabilization Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.2950
Definition	Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.