Cleared Traditional

K103574 - PREGNANCY ONE STEP RAPID TEST

K103574 is an FDA 510(k) clearance for PREGNANCY ONE STEP RAPID TEST, manufactured by Lehnus & Associates Consulting. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K103574 · Lehnus & Associates Consulting · Chemistry device
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Jul 2011
Decision
234d
Days
Class 2
Risk

K103574 is an FDA 510(k) clearance for the PREGNANCY ONE STEP RAPID TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Lehnus & Associates Consulting (East Stroudsburg, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 234 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.

FDA 510(k) Submission Details - K103574

510(k) Number K103574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date July 28, 2011
Days to Decision 234 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
146d slower than avg
Panel avg: 88d · This submission: 234d
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 202
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K103574.
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
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
K102760 · Atlas Medical · Aug 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889 · Ind Diagnostics, Inc. · Jun 2011
CLEARBLUE EASY PREGNANCY TEST
K110433 · SPD Development Company Limited · May 2011
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150 · Turklab Medical Devices, Inc. · Jun 2009
K103574 · PREGNANCY ONE STEP RAPID TEST
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