Onclarity Self-Collection Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Onclarity EUDAMED
- Device Name
- BD Onclarity™ HPV Self-Collection Dry Tube Bulk EUDAMED
- Model / Reference
- 440381 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382904403813 EUDAMED
- Basic UDI-DI
- 038290OSNCGZEUH5 EUDAMED
- Unit of Use DI
- 00382904403812 EUDAMED
- 510(k) Number
- K260184 FDA 510(k)
- FDA Product Code
- SEP FDA 510(k)
- EMDN Code
- W050301020102 SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2920 FDA 510(k)
- Regulation Number
- 866.2920 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
The Onclarity Self-Collection Kit is a Device for Home Collection and Transport of Vaginal Specimens by Lay Users for use in an approved HPV molecular assay. It is classified as a Class II microbiology device under FDA product code SEP, designed to enable self-collection of vaginal specimens outside clinical settings.
The kit is intended for single-use and is supplied sterile for at-home specimen collection and transport. It is regulated under FDA 510(k) clearance (K260184) and IVDR compliance, with no MRI safety restrictions. Storage and handling follow standard sterile medical device protocols as specified in the manufacturer’s instructions.
Frequently asked questions
What is the Onclarity Self-Collection Kit designed for, and who can use it?
The Onclarity Self-Collection Kit is designed for at-home collection and transport of vaginal specimens by lay users—meaning individuals without clinical training—specifically for use in an approved HPV molecular assay. It enables self-sampling outside traditional clinical settings, making it accessible for home use.
Is the Onclarity Self-Collection Kit intended for reuse, or is it single-use only?
The kit is explicitly intended for single-use only. It is supplied sterile to ensure specimen integrity and safety for one-time collection and transport, preventing cross-contamination or degradation of the sample.
How should the Onclarity Self-Collection Kit be stored, and what precautions should be taken?
The kit follows standard sterile medical device protocols for storage and handling, as outlined in the manufacturer’s instructions. Since it is sterile and single-use, it should be stored in a clean, dry environment, protected from moisture, extreme temperatures, and physical damage to maintain its sterility and functionality.
Are there any special considerations for using the Onclarity Self-Collection Kit in medical imaging environments?
No, the kit has no MRI safety restrictions, meaning it can be safely used in environments where MRI scans are performed without interference or risk. This is explicitly stated in the device documentation.
What regulatory pathways does the Onclarity Self-Collection Kit follow, and how does that affect its use?
The kit is cleared under FDA’s 510(k) pathway (K260184) and complies with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone regulatory review to ensure safety, performance, and conformity with applicable standards before being authorized for use in the U.S. and EU markets, respectively.
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: Onclarity™ Self-Collection Kit (K260184) — FDA 510 (k) | Innolitics, K260184 - Onclarity Self-Collection Kit | FDA 510 (k), Waters Announces FDA Clearance of the Most Comprehensive At-Home ..., Onclarity Self-Collection Kit-COR (UDI: 445444) Specs & FDA Data
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 | K260184 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (2)
- FDA 510(k) K260184 24 fields · synced Sep 18, 2026
- EUDAMED a89eea68-30c7-4521-8c6c-634b009bdc0f 61 fields · synced Jul 10, 2026