Cleared Traditional

K883709 - MODIFICATION OF MONO-PLUS(TM)

K883709 is an FDA 510(k) clearance for MODIFICATION OF MONO-PLUS(TM), manufactured by Armkel, LLC. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K883709 · Armkel, LLC · Immunology device
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Dec 1988
Decision
112d
Days
Class 2
Risk

K883709 is an FDA 510(k) clearance for the MODIFICATION OF MONO-PLUS(TM). Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on December 20, 1988 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Armkel, LLC devices

FDA 510(k) Submission Details - K883709

510(k) Number K883709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date December 20, 1988
Days to Decision 112 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
7d slower than avg
Panel avg: 105d · This submission: 112d
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 K883709.
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · Quidel Corp. · Jun 1989
MONO-CUBE(TM)
K890991 · Difco Laboratories, Inc. · Mar 1989
V-TREND TARGET IM TEST
K890041 · Texas Immunology, Inc. · Jan 1989
CARDS(TM) MONO
K884007 · Pacific Biotech, Inc. · Nov 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · Unipath , Ltd. · Oct 1988
V-TREND IM DRY-SPOT TEST
K880399 · Texas Immunology, Inc. · Feb 1988