Cleared Traditional

K864373 - CLEARBLUE PREGNANCY TESTING KIT (MODIFI...

K864373 is the FDA 510(k) clearance for CLEARBLUE PREGNANCY TESTING KIT (MODIFI... by Unipath , Ltd.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K864373 · Unipath , Ltd. · Chemistry device
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Jan 1987
Decision
65d
Days
Class 2
Risk

K864373 is an FDA 510(k) clearance for the CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION). 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 January 9, 1987 after a review of 65 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.

View all Unipath , Ltd. devices

Submission Details

510(k) Number K864373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date January 09, 1987
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K864373.
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · Leeco Diagnostics, Inc. · Feb 1988
ABBOTT BIOTELL PREGNANCY TEST
K871996 · Abbott Laboratories · Aug 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · Leeco Diagnostics, Inc. · Jan 1987
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · Hybritech, Inc. · Dec 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · Quidel Corp. · Jun 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · Unipath , Ltd. · Apr 1986