Cleared Traditional

K123567 - FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST

K123567 is an FDA 510(k) clearance for FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST, manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K123567 · Church & Dwight Co., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
294d
Days
Class 2
Risk

K123567 is an FDA 510(k) clearance for the FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on September 10, 2013 after a review of 294 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K123567

510(k) Number K123567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2012
Decision Date September 10, 2013
Days to Decision 294 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 88d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 165
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K123567.
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
K150022 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2015
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085 · Co-Innovation Biotech Co., Ltd. · Nov 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
K131236 · Ucp Biosciences, Inc. · Nov 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
K123436 · Church & Dwight Co., Inc. · Aug 2013
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
K131931 · Chemtron Biotech, Inc. · Jul 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
K123703 · Healgen Scientific, LLC · Apr 2013