Cleared Traditional

K841863 - MONO-TEC

K841863 is an FDA 510(k) clearance for MONO-TEC, manufactured by Medilab Corp.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K841863 · Medilab Corp. · Immunology device
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Jun 1984
Decision
40d
Days
Class 2
Risk

K841863 is an FDA 510(k) clearance for the MONO-TEC. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Medilab Corp. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1984 after a review of 40 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 Medilab Corp. devices

FDA 510(k) Submission Details - K841863

510(k) Number K841863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1984
Decision Date June 13, 1984
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 105d · This submission: 40d
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 43
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K841863.
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · Gamma Biologicals, Inc. · Apr 1986
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
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
SERO/TEX MONO TEST
K821386 · Texas Immunology, Inc. · Jul 1982