Cleared Traditional

K260184 - Onclarity™ Self-Collection Kit (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence.

K260184 · Becton, Dickinson and Company · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
71d
Days
Class 2
Risk

K260184 is an FDA 510(k) clearance for the Onclarity™ Self-Collection Kit. Classified as Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay (product code SEP), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on April 2, 2026 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2920 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K260184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2026
Decision Date April 02, 2026
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 102d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2920
Definition A Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Hpv Testing Is A Device Intended For Use By Lay Users In Home Settings Or Similar Environments For The Collection And Transportation Of Vaginal Specimens For Testing Using An Approved Hpv Molecular Assay With Which The Device Has Been Validated.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06498661 Active not recruiting Interventional NIH-sponsored

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01

750
Patients (est.)
15
Sites
Prevention
Purpose
Open label
Masking
Condition studied Cervical Carcinoma; Human Papillomavirus Infection
Study design Parallel
Eligibility Female only · 25 Years+ · Healthy volunteers accepted
Principal investigator Vikrant V Sahasrabuddhe
Sponsor National Cancer Institute (NCI)
Started 2024-06-26 → Primary completion 2026-12-30 → Completed 2027-06-30
Primary outcome
Clinical sensitivity for self-collected (SC) samples (Group A)
View full study on ClinicalTrials.gov

Regulatory Peers - SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Devices cleared under the same product code (SEP) and FDA review panel - the closest regulatory comparables to K260184.
Teal Wand
DEN240045 · Teal Health, Inc. · May 2025