K190613 is an FDA 510(k) clearance for the BD MAX Check-Points CPO. This device is classified as a System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen (Class II - Special Controls, product code POC).
Submitted by Check-Points Health B.V. (Wageningen, NL). The FDA issued a Cleared decision on August 29, 2019, 171 days after receiving the submission on March 11, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology..
| 510(k) Number | K190613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2019 |
| Decision Date | August 29, 2019 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | POC - System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen |
| 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 Directly From Clinical Specimens Using Nucleic Acid Amplification Technology. |