K200866 is an FDA 510(k) clearance for the Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System). This device is classified as a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II - Special Controls, product code QEP).
Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on May 17, 2020, 46 days after receiving the submission on April 1, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3393. A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data..
| 510(k) Number | K200866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2020 |
| Decision Date | May 17, 2020 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QEP — Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3393 |
| Definition | A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data. |