Cleared Traditional

K023027 - PREG-Q EARLY PREGNANCY TEST

K023027 is an FDA 510(k) clearance for PREG-Q EARLY PREGNANCY TEST, manufactured by Yd Diagnostics. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K023027 · Yd Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
96d
Days
Class 2
Risk

K023027 is an FDA 510(k) clearance for the PREG-Q EARLY PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Yd Diagnostics (Appollo Beach, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 96 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 Yd Diagnostics devices

FDA 510(k) Submission Details - K023027

510(k) Number K023027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date December 16, 2002
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
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 157
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K023027.
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510 · ACON Laboratories, Inc. · Sep 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · Unipath , Ltd. · May 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · Armkel, LLC · Feb 2003
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · Unipath , Ltd. · Nov 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · Unipath , Ltd. · Nov 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · ACON Laboratories, Inc. · Aug 2001