Cleared Special

K032939 - EPT CERTAINTY PREGNANCY TEST

K032939 is an FDA 510(k) clearance for EPT CERTAINTY 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 28-day FDA review.

K032939 · Unipath , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
28d
Days
Class 2
Risk

K032939 is an FDA 510(k) clearance for the EPT CERTAINTY 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 October 20, 2003 after a review of 28 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 - K032939

510(k) Number K032939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date October 20, 2003
Days to Decision 28 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
61d faster than avg
Panel avg: 89d · This submission: 28d
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 K032939.
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
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
CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
K032159 · Access Bio Incorporate · Sep 2003
K032939 · EPT CERTAINTY PREGNANCY TEST
Download PDF Unipath , Ltd.