Cleared Traditional

K083716 - FIRST RESPONSE EARLY RESULT PREGNANCY T...

K083716 is the FDA 510(k) clearance for FIRST RESPONSE EARLY RESULT PREGNANCY T... by Church & Dwight Co., Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K083716 · Church & Dwight Co., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
175d
Days
Class 2
Risk

K083716 is an FDA 510(k) clearance for the FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC). 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 June 8, 2009 after a review of 175 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

Submission Details

510(k) Number K083716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date June 08, 2009
Days to Decision 175 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 88d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K083716.
ACRO HCG Pregnancy Rapid Test
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