Cleared Traditional

K023037 - MID STREAM PREGNANCY TEST

K023037 is an FDA 510(k) clearance for MID STREAM PREGNANCY TEST, manufactured by Advanced Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K023037 · Advanced Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
209d
Days
Class 2
Risk

K023037 is an FDA 510(k) clearance for the MID STREAM PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Advanced Diagnostics, Inc. (So. Plainfield, US). The FDA issued a Cleared decision on April 9, 2003 after a review of 209 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.

View all Advanced Diagnostics, Inc. devices

FDA 510(k) Submission Details - K023037

510(k) Number K023037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date April 09, 2003
Days to Decision 209 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
121d slower than avg
Panel avg: 88d · This submission: 209d
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 162
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K023037.
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661 · ACON Laboratories, Inc. · Oct 2003
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