Cleared Traditional

K883709 - MODIFICATION OF MONO-PLUS(TM)

K883709 is the FDA 510(k) clearance for MODIFICATION OF MONO-PLUS(TM) by Armkel, LLC. It is a Class 2 Immunology device (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

Submission Details

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
8d slower than avg
Panel avg: 104d · This submission: 112d
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 25
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K883709.
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · Gull Laboratories, Inc. · Oct 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · Quidel Corp. · Jun 1989
MONO-CUBE(TM)
K890991 · Difco Laboratories, Inc. · Mar 1989
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · Unipath , Ltd. · Oct 1988
DIFFERENTIAL I.M. SCREENING TEST
K873297 · Sclavo, Inc. · Dec 1987
VENTRESCREEN (TM) MONO
K872032 · Ventrex Laboratories, Inc. · Jun 1987