Cleared Traditional

K840822 - LEAP MONO TEST KIT

K840822 is the FDA 510(k) clearance for LEAP MONO TEST KIT by Cooper Biomedical, Inc.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K840822 · Cooper Biomedical, Inc. · Immunology device
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Apr 1984
Decision
41d
Days
Class 2
Risk

K840822 is an FDA 510(k) clearance for the LEAP MONO TEST KIT. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Cooper Biomedical, Inc. (Walker, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5640 - the FDA immunology device 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 Cooper Biomedical, Inc. devices

Submission Details

510(k) Number K840822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date April 05, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTN System, Test, Infectious Mononucleosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5640
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 Immunology devices follow this clearance model.

Regulatory Peers - KTN System, Test, Infectious Mononucleosis

All 26
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K840822.
MONO-LATEX (TM) SLIDE TEST
K862008 · Armkel, LLC · Jul 1986
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984
CORDIA IM
K812540 · Cordis Corp. · Sep 1981
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455 · Volu Sol Medical Industries · Dec 1979
MONOSTICON TEST
K771397 · Organon, Inc. · Aug 1977