Cleared Traditional

K861168 - CLEARBLUE PREGNANCY TESTING KIT

K861168 is an FDA 510(k) clearance for CLEARBLUE PREGNANCY TESTING KIT, manufactured by Unipath , Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K861168 · Unipath , Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1986
Decision
27d
Days
Class 2
Risk

K861168 is an FDA 510(k) clearance for the CLEARBLUE PREGNANCY TESTING KIT. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on April 24, 1986 after a review of 27 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K861168

510(k) Number K861168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date April 24, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 89d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K861168.
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · Hybritech, Inc. · Dec 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · Quidel Corp. · Jun 1986
PTK PLUS. HOME PREGNANCY TEST
K861946 · Healthcheck Corp. · Jun 1986
MUREX (TM), SUDS (TM), HCG ASSAY
K860451 · Murex Corp. · Apr 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · Armkel, LLC · Apr 1986
PREGNA/TEST
K853269 · Modern Diagnostics, Inc. · Oct 1985
K861168 · CLEARBLUE PREGNANCY TESTING KIT
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