Aptima Neisseria gonorrhoeae Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231329 FDA 510(k)
- FDA Product Code
- LSL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3390 FDA 510(k)
- Regulation Number
- 866.3390 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aptima Neisseria gonorrhoeae Assay is an in vitro nucleic acid probe test designed for the qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (gonorrhea). It employs target capture and amplification technology to aid in diagnosing gonococcal urogenital infections, aligning with the classification of DNA reagents for microbiological testing.
This assay is intended for use on the Tigris DTS System or semi-automated instrumentation as specified. Supplied as a single-use reagent, it requires no sterilization beyond its sterile packaging. The device is classified under FDA 510(k) and IVDR regulations, with a product code of LSL and regulation number 866.3390. Storage and handling must adhere to manufacturer guidelines to maintain assay integrity.
Frequently asked questions
What clinical purpose does the Aptima Neisseria gonorrhoeae Assay serve in a laboratory setting?
The Aptima Neisseria gonorrhoeae Assay is designed for the qualitative detection of ribosomal RNA (rRNA) from *Neisseria gonorrhoeae*, the bacterium responsible for gonorrhea. It aids in diagnosing gonococcal urogenital infections by using nucleic acid probe technology to capture and amplify target sequences, helping confirm the presence of the infection in clinical samples.
How is the Aptima Neisseria gonorrhoeae Assay supplied, and is it reusable?
The assay is supplied as a single-use reagent, meaning each test kit is intended for one use only. It comes in sterile packaging, so no additional sterilization is required before use. This design ensures consistency and reduces the risk of contamination between tests.
Which systems are compatible with the Aptima Neisseria gonorrhoeae Assay, and how does this affect workflow?
The assay is intended for use exclusively on the Tigris DTS System or semi-automated instrumentation as specified by the manufacturer. This compatibility ensures seamless integration into laboratory workflows, automating key steps like target capture and amplification while maintaining accuracy and efficiency for gonorrhea testing.
Are there specific storage or handling requirements for the Aptima Neisseria gonorrhoeae Assay to maintain its integrity?
Yes, the assay must be stored and handled according to the manufacturer’s guidelines to preserve its performance. While the exact conditions aren’t detailed here, proper storage typically involves protecting it from extreme temperatures, light, and physical damage. Adhering to these instructions ensures the assay remains effective for its intended use in detecting *Neisseria gonorrhoeae*.
What regulatory pathways does the Aptima Neisseria gonorrhoeae Assay follow, and how does this impact its use?
The assay has been authorized through both the FDA’s 510(k) pathway and the In Vitro Diagnostic Regulation (IVDR) in the EU. This means it has undergone evaluation for safety, performance, and compliance with regulatory standards in these regions. Clinicians and laboratories can rely on its authorized status for use in diagnosing gonorrhea, ensuring it meets established benchmarks for accuracy and reliability.
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 Neisseria gonorrhoeae Assay | Hologic, Aptima® Neisseria Gonorrhoeae Assay | STI | Hologic® Canada, PDF Aptima Neisseria gonorrhoeae Assay - Hologic, Aptima® Neisseria Gonorrhoeae Assay | STI | Hologic® Australia
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 | K231329 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA 510(k) K231329 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026