510(k) K191288
K191288 is an FDA 510(k) premarket notification submitted by Opgen, Inc. for the device "Acuitas AMR Gene Panel". The FDA issued a decision of Substantially Equivalent on September 30, 2021. The device falls under product code PMY (System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony), a Class II device regulated under 21 CFR 866.1640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2021
- Date Received
- May 13, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.