Cleared Special

K061769 - E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

K061769 is an FDA 510(k) clearance for E.P.T. CERTAINTY 1-STEP 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 10-day FDA review.

K061769 · Unipath , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
10d
Days
Class 2
Risk

K061769 is an FDA 510(k) clearance for the E.P.T. CERTAINTY 1-STEP 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 July 3, 2006 after a review of 10 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 - K061769

510(k) Number K061769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2006
Decision Date July 03, 2006
Days to Decision 10 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
79d faster than avg
Panel avg: 89d · This submission: 10d
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 K061769.
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K061769 · E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
Download PDF Unipath , Ltd.