Cleared Special

K040329 - MODIFICATION TO E.P.T. PREGNANCY TEST

K040329 is an FDA 510(k) clearance for MODIFICATION TO E.P.T. PREGNANCY TEST, manufactured by Unipath , Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Special 510(k) pathway after a 26-day FDA review.

K040329 · Unipath , Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
26d
Days
Class 2
Risk

K040329 is an FDA 510(k) clearance for the MODIFICATION TO E.P.T. PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on March 8, 2004 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040329

510(k) Number K040329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2004
Decision Date March 08, 2004
Days to Decision 26 days
Submission Type Special
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
63d faster than avg
Panel avg: 89d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K040329.
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
K041748 · Azog, Inc. · Aug 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404 · Unipath , Ltd. · Jun 2004
ONE-STEP PREGNANCY TEST
K041273 · W.H.P.M., Inc. · May 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · Unipath , Ltd. · Mar 2004
E.P.T. PREGNANCY TEST
K033658 · Unipath , Ltd. · Jan 2004
UNIMARK HOME PREGNANCY TEST DEVICE
K032992 · Biotech Atlantic, Inc. · Nov 2003
K040329 · MODIFICATION TO E.P.T. PREGNANCY TEST
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