Cleared Traditional

Acuitas AMR Gene Panel

K191288 · Opgen, Inc. · Microbiology
Sep 2021
Decision
871d
Days
Class 2
Risk

About This 510(k) Submission

K191288 is an FDA 510(k) clearance for the Acuitas AMR Gene Panel, a System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony (Class II — Special Controls, product code PMY), submitted by Opgen, Inc. (Rockville, US). The FDA issued a Cleared decision on September 30, 2021, 871 days after receiving the submission on May 13, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K191288 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2019
Decision Date September 30, 2021
Days to Decision 871 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology.