Cleared Traditional

K993483 - ACON ONE STEP HOME PREGNANCY TEST STRIP

K993483 is the FDA 510(k) clearance for ACON ONE STEP HOME PREGNANCY TEST STRIP by ACON Laboratories, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K993483 · ACON Laboratories, Inc. · Chemistry device
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Jan 2000
Decision
98d
Days
Class 2
Risk

K993483 is an FDA 510(k) clearance for the ACON ONE STEP HOME PREGNANCY TEST STRIP. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 98 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K993483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1999
Decision Date January 20, 2000
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K993483.
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
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · Armkel, LLC · Dec 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · Unipath , Ltd. · Dec 1999
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · Phamatech · Nov 1999