Gonosticon Dri-Dot Test Kit
FDA PMAFDA 510(k)Class I (US FDA PMA)
Identity
- Trade Name
- GONOSTICON DRI-DOT TEST FDA PMA
- Generic Name
- KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.5640 FDA PMA
- Regulation Number
- 866.5640 FDA PMA
- Advisory Committee
- Immunology FDA PMA
- FDA Decision
- SESE Substantially Equivalent FDA PMA
- PMA Supplement
- S002 FDA PMA
The Gonosticon Dri-Dot Test Kit is an identification kit for Neisseria gonorrhoeae, a bacterial pathogen responsible for gonorrhea. Classified as a diagnostic test system, it detects the presence of gonococcal antigens in clinical specimens, aiding in the confirmation of gonorrhea infections.
This test is supplied as a single-use diagnostic kit and is intended for use in clinical laboratory settings. Sterility is not specified, but the device is regulated under FDA 510(k) clearance (K771397) and PMA (N17985), adhering to 21 CFR 866.5640. No MRI safety information is provided, and the kit is not reusable. Storage conditions are not detailed in the specifications.
Frequently asked questions
What clinical setting is the Gonosticon Dri-Dot Test designed for, and why is this important for users?
The Gonosticon Dri-Dot Test is specifically intended for use in clinical laboratory settings, where trained personnel can perform diagnostic testing. This distinction is important because it ensures the test is administered in an environment with proper infrastructure, quality control, and expertise to interpret results accurately for diagnosing *Neisseria gonorrhoeae* infections.
Is the Gonosticon Dri-Dot Test reusable, and if not, how does this affect its use in a clinical workflow?
No, the Gonosticon Dri-Dot Test is single-use only, as explicitly stated in the device description. This design ensures patient safety and test accuracy by preventing cross-contamination between specimens, which is critical for reliable diagnostic results. Clinicians must order a new kit for each test to avoid reuse.
What type of specimens does the Gonosticon Dri-Dot Test detect, and how does this differ from other gonorrhea diagnostic methods?
The Gonosticon Dri-Dot Test detects gonococcal antigens in clinical specimens, confirming the presence of *Neisseria gonorrhoeae*—the bacterium responsible for gonorrhea. Unlike culture-based methods or nucleic acid amplification tests (NAATs), this kit provides a rapid antigen-based identification, which can be particularly useful for point-of-care or preliminary screening in laboratory settings where immediate results are beneficial.
Are there any special storage requirements for the Gonosticon Dri-Dot Test, and what should clinicians know about handling it?
The device specifications do not explicitly detail storage conditions, which means it should be stored according to standard laboratory protocols for diagnostic test kits—typically at room temperature, protected from extreme temperatures, light, and moisture. Clinicians should verify the manufacturer’s latest instructions for optimal shelf life and stability, as improper storage could compromise test performance.
How does the regulatory pathway for the Gonosticon Dri-Dot Test (FDA 510(k) and PMA) influence its use in clinical practice?
The Gonosticon Dri-Dot Test holds both FDA 510(k) clearance (K771397) and a Premarket Approval (PMA, N17985), indicating it has undergone rigorous evaluation for safety and effectiveness as a diagnostic device. This dual pathway ensures the test meets stringent standards for detecting *Neisseria gonorrhoeae* antigens, giving clinicians confidence in its reliability for confirming gonorrhea infections in laboratory settings. The classification under 21 CFR 866.5640 also aligns it with other immunology-based diagnostic tests.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771397 | Class I | Active |
| FDA PMA | United States | FDA_PMA | N17985 | Class I | Active |
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Manufacturer
- Manufacturer
- Organon, Inc.
Sources (2)
- FDA PMA N17985 36 fields · synced Sep 18, 2026
- FDA 510(k) K771397 1 fields · synced May 18, 2026