Cleared Traditional

K123703 - HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)

K123703 is an FDA 510(k) clearance for HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), manufactured by Healgen Scientific, LLC. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K123703 · Healgen Scientific, LLC · Chemistry device
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Apr 2013
Decision
128d
Days
Class 2
Risk

K123703 is an FDA 510(k) clearance for the HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY T.... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on April 10, 2013 after a review of 128 days - within the typical 510(k) review window.

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 Healgen Scientific, LLC devices

FDA 510(k) Submission Details - K123703

510(k) Number K123703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date April 10, 2013
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
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 K123703.
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
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
K131931 · Chemtron Biotech, Inc. · Jul 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
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · Tianjin New Bay Bioresearch Co., Ltd. · Sep 2012