Cleared Traditional

K161544 - Trojan Chain Reaction Personal Lubricant

K161544 is an FDA 510(k) clearance for Trojan Chain Reaction Personal Lubricant, manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K161544 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
89d
Days
Class 2
Risk

K161544 is an FDA 510(k) clearance for the Trojan Chain Reaction Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 31, 2016 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology 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 Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K161544

510(k) Number K161544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2016
Decision Date August 31, 2016
Days to Decision 89 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 160d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
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 Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02737618 Completed Interventional Industry-sponsored

14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon

35
Patients (actual)
1
Site
Screening
Purpose
Open label
Masking
Condition studied Dermal Irritation
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator John Dosik, MD
Sponsor Church & Dwight Company, Inc. (industry)
Started 2016-02-01 → Primary completion 2016-03-01
Primary outcome
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
View full study on ClinicalTrials.gov

Regulatory Peers - NUC Lubricant, Personal

All 212
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