Cleared Traditional

K860451 - MUREX (TM)

K860451 is the FDA 510(k) clearance for MUREX (TM) by Murex Corp.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K860451 · Murex Corp. · Chemistry device
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Apr 1986
Decision
75d
Days
Class 2
Risk

K860451 is an FDA 510(k) clearance for the MUREX (TM), SUDS (TM), HCG ASSAY. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Murex Corp. (Norcross, US). The FDA issued a Cleared decision on April 21, 1986 after a review of 75 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 Murex Corp. devices

Submission Details

510(k) Number K860451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1986
Decision Date April 21, 1986
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K860451.
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
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · Armkel, LLC · Apr 1986
ANSWER
K852274 · Armkel, LLC · Jun 1985
ANSWER ONE-DAY
K843238 · Armkel, LLC · Sep 1984