Cleared Special

K050930 - E.P.T. CERTAINTY PREGNANCY TEST

K050930 is the FDA 510(k) clearance for E.P.T. CERTAINTY PREGNANCY TEST by Unipath , Ltd.. It is a Class 2 Chemistry device (product code LCX) cleared through the Special 510(k) pathway after a 28-day FDA review.

K050930 · Unipath , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
28d
Days
Class 2
Risk

K050930 is an FDA 510(k) clearance for the E.P.T. 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 May 12, 2005 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.

View all Unipath , Ltd. devices

Submission Details

510(k) Number K050930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date May 12, 2005
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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K050930.
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd. · Jul 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006
ACON +/- MIDSTREAM PREGNANCY TEST
K050546 · ACON Laboratories, Inc. · May 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2005
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · Armkel, LLC · Oct 2004
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · Unipath , Ltd. · Sep 2004