Cleared Traditional

K123050 - EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

K123050 is an FDA 510(k) clearance for EGENS ONE STEP HCG URINE PREGNANCY TEST..., manufactured by Nantong Biotechnology Co., Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K123050 · Nantong Biotechnology Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
130d
Days
Class 2
Risk

K123050 is an FDA 510(k) clearance for the EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I .... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Nantong Biotechnology Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on February 5, 2013 after a review of 130 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 Nantong Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K123050

510(k) Number K123050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date February 05, 2013
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
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 174
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K123050.
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
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · Polymed Therapeutics, Inc. · Mar 2013
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · Tianjin New Bay Bioresearch Co., Ltd. · Sep 2012
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
PREGNANCY ONE STEP RAPID TEST
K103574 · Lehnus & Associates Consulting · Jul 2011