K191742 is an FDA 510(k) clearance for the ARIES MRSA Assay. This device is classified as a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II - Special Controls, product code NQX).
Submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on September 25, 2019, 86 days after receiving the submission on July 1, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings..
| 510(k) Number | K191742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2019 |
| Decision Date | September 25, 2019 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NQX - System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings. |