Cleared Traditional

K023126 - AMEDITECH IMMUTEST HCG PREGANCY TEST

K023126 is the FDA 510(k) clearance for AMEDITECH IMMUTEST HCG PREGANCY TEST by Ameditech, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K023126 · Ameditech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
60d
Days
Class 2
Risk

K023126 is an FDA 510(k) clearance for the AMEDITECH IMMUTEST HCG PREGANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Ameditech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 18, 2002 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ameditech, Inc. devices

Submission Details

510(k) Number K023126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2002
Decision Date November 18, 2002
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K023126.
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
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483 · ACON Laboratories, Inc. · Jan 2000