Cleared Traditional

K131931 - CHEMTRUE HCG PREGNANCY URINE MIDSTREAM TEST

K131931 is an FDA 510(k) clearance for CHEMTRUE HCG PREGNANCY URINE MIDSTREAM TEST, manufactured by Chemtron Biotech, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K131931 · Chemtron Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
29d
Days
Class 2
Risk

K131931 is an FDA 510(k) clearance for the CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Chemtron Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 26, 2013 after a review of 29 days - a notably fast clearance 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: 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 Chemtron Biotech, Inc. devices

FDA 510(k) Submission Details - K131931

510(k) Number K131931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date July 26, 2013
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 126
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K131931.
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
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K123567 · Church & Dwight Co., Inc. · Sep 2013
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K123436 · Church & Dwight Co., Inc. · Aug 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
K123703 · Healgen Scientific, LLC · Apr 2013
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · Church & Dwight Co., Inc. · Jun 2009