Cleared Traditional

K042272 - ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)

K042272 is an FDA 510(k) clearance for ACON MONONUCLEOSIS RAPID TEST STRIP (WH..., manufactured by ACON Laboratories, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K042272 · ACON Laboratories, Inc. · Immunology device
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Feb 2005
Decision
189d
Days
Class 2
Risk

K042272 is an FDA 510(k) clearance for the ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA). Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 189 days - an extended review 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: 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 ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K042272

510(k) Number K042272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date February 28, 2005
Days to Decision 189 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 105d · This submission: 189d
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 K042272.
OSOM Mono Test
K181436 · SEKISUI Diagnostics, LLC · Jun 2018
BIORAPID MONONUCLEOSIS
K030215 · Instrumentation Laboratory CO · Feb 2003
COLOR-MONOGEN
K012901 · Instrumentation Laboratory CO · Sep 2001
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · Oxoid , Ltd. · Jan 1999
CLEARVIEW IM
K981946 · Unipath , Ltd. · Dec 1998
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc., · Dec 1997