Cleared Traditional

ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (K042272) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042272 · ACON Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 104d · This submission: 189d
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 58
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
CORDIA IM
K812540 · Cordis Corp. · Sep 1981
TEST, MONO., CARD (MACRO-VUE)
K760040 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976