Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220321 FDA 510(k)
- FDA Product Code
- QEP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3393 FDA 510(k)
- Regulation Number
- 866.3393 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aptima Combo 2 Assay and Aptima Trichomonas Vaginalis Assay are nucleic acid detection systems designed for the in vitro qualitative detection of ribosomal RNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. These assays utilize target capture and amplification techniques to differentiate and identify these sexually transmitted microorganisms, aiding in the diagnosis of associated infections.
The assays are supplied as 250-test kits for use on the Panther or Tigris automated platforms in clinical laboratory settings. They are intended for single-use and require no additional sterilization. Compliance is evidenced by FDA 510(k) clearance under Special Review (K220321) and IVDR conformity, with regulatory classification as Class II devices (866.3393). Storage and handling follow manufacturer guidelines for nucleic acid assays, ensuring stability and performance within specified conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aptima® Combo 2 Assay | CT/NG Diagnostic Testing | Hologic, Aptima Combo 2 Assay for CT/NG Package Insert | Hologic, PDF Aptima Combo 2 Assay (Panther System) Package Insert - Hologic, Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220321 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA 510(k) K220321 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026