Cleared Traditional

InActiv Blue

K221547 · Fertipro NV · Microbiology

Jun 2024

Decision

746d

Days

Class 2

Risk

About This 510(k) Submission

K221547 is an FDA 510(k) clearance for the InActiv Blue, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Fertipro NV (Beernem, BE). The FDA issued a Cleared decision on June 11, 2024, 746 days after receiving the submission on May 27, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K221547 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2022
Decision Date	June 11, 2024
Days to Decision	746 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.