Cleared Traditional

DNA/RNA Shield SafeCollect Saliva Collection kit

K231013 · Zymo Research · Microbiology

Sep 2023

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K231013 is an FDA 510(k) clearance for the DNA/RNA Shield SafeCollect Saliva Collection kit, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Zymo Research (Irvine, US). The FDA issued a Cleared decision on September 28, 2023, 171 days after receiving the submission on April 10, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K231013 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2023
Decision Date	September 28, 2023
Days to Decision	171 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.