Cleared Special

K033658 - E.P.T. PREGNANCY TEST

K033658 is an FDA 510(k) clearance for 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 56-day FDA review.

K033658 · Unipath , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
56d
Days
Class 2
Risk

K033658 is an FDA 510(k) clearance for the 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 January 16, 2004 after a review of 56 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 - K033658

510(k) Number K033658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date January 16, 2004
Days to Decision 56 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
33d faster than avg
Panel avg: 89d · This submission: 56d
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 K033658.
ONE-STEP PREGNANCY TEST
K041273 · W.H.P.M., Inc. · May 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · Unipath , Ltd. · Mar 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · Unipath , Ltd. · Mar 2004
UNIMARK HOME PREGNANCY TEST DEVICE
K032992 · Biotech Atlantic, Inc. · Nov 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
K033041 · ACON Laboratories, Inc. · Nov 2003
GOOD MORNING TEST
K031798 · Standard Diagnostics, Inc. · Nov 2003
K033658 · E.P.T. PREGNANCY TEST
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