Cleared Traditional

K131931 - CHEMTRUE(R) 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 179
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K131931.
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 GOLD DIGITAL PREGNANCY TEST
K123567 · Church & Dwight Co., Inc. · Sep 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
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
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · Polymed Therapeutics, Inc. · Mar 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
K123050 · Nantong Biotechnology Co., Ltd. · Feb 2013