Cleared Traditional

K853388 - MONOSTICON UNI-DOT

K853388 is an FDA 510(k) clearance for MONOSTICON UNI-DOT, manufactured by Organon, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K853388 · Organon, Inc. · Immunology device
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Aug 1985
Decision
9d
Days
Class 2
Risk

K853388 is an FDA 510(k) clearance for the MONOSTICON UNI-DOT. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Organon, Inc. (West Orange, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 9 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 Organon, Inc. devices

FDA 510(k) Submission Details - K853388

510(k) Number K853388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1985
Decision Date August 22, 1985
Days to Decision 9 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 105d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTN Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K853388.
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · Gamma Biologicals, Inc. · Dec 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · Armkel, LLC · Jul 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · Gamma Biologicals, Inc. · Apr 1986
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984
LEAP MONO TEST KIT
K840822 · Cooper Biomedical, Inc. · Apr 1984
IM-CHECK
K834345 · Diagnostic Technology, Inc. · Feb 1984