Product Code: KTN FDA class 2 21 CFR 866.5640

System, Test, Infectious Mononucleosis

Immunology

The Infectious Mononucleosis Test System is an in vitro diagnostic device used to detect heterophile antibodies or Epstein-Barr virus-specific antibodies in patient samples to aid in the diagnosis of infectious mononucleosis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before it can be marketed. The product code is KTN, regulated under 21 CFR 866.5640, in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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FEI Numbers

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Basic Information

Product Code: KTN
Device Class: FDA class 2
Regulation Number: 866.5640
Medical Specialty: Immunology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 59 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K181436	OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test	Jun 22, 2018	Substantially Equivalent	SEKISUI Diagnostics, LLC
K042272	ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)	Feb 28, 2005	Substantially Equivalent	ACON Laboratories, Inc.
K030215	BIORAPID MONONUCLEOSIS	Feb 24, 2003	Substantially Equivalent	Instrumentation Laboratory CO
K012901	COLOR-MONOGEN	Sep 27, 2001	Substantially Equivalent	Instrumentation Laboratory CO
K982634	DRYSPOT INFECTIOUS MONONUCLEOSIS KIT	Jan 28, 1999	Substantially Equivalent	Oxoid , Ltd.
K981946	CLEARVIEW IM	Dec 10, 1998	Substantially Equivalent	Unipath , Ltd.
K972457	MONOCOL/LEX-IM TEST	Dec 01, 1997	Substantially Equivalent	Immunostics Inc.,
K972231	OSOM MONO TEST 143	Aug 26, 1997	Substantially Equivalent	Wyntek Diagnostics, Inc.
K963425	GENZYME DIAGNOSTICS CONTRAST MONO	Feb 25, 1997	Substantially Equivalent	Genzyme Diagnostics
K961024	BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB	Feb 04, 1997	Substantially Equivalent	Princeton BioMeditech Corp.
K961550	QUALITROL MONO CONTROL SERUM SET	Sep 24, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K930778	IMMUNOCARD MONO	Dec 27, 1993	Substantially Equivalent	Meridian Diagnostics, Inc.
K932688	EYE SPOT IM TEST	Sep 08, 1993	Substantially Equivalent	J.S. Medical Assoc.
K932551	ACCUTEX IM LATEX TEST	Aug 09, 1993	Substantially Equivalent	J.S. Medical Assoc.
K925183	BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST	Feb 23, 1993	Substantially Equivalent	Princeton Biomedix
K924037	ACCUTEX IM RBC TEST	Nov 02, 1992	Substantially Equivalent	J.S. Medical Assoc.
K923767	PULSE IM RED CELL TEST	Oct 16, 1992	Substantially Equivalent	Pulse Scientific, Inc.
K922726	TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL	Oct 05, 1992	Substantially Equivalent	Simplicity Diagnostics, Inc.
K922297	INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST	Jul 14, 1992	Substantially Equivalent	Ampcor, Inc.
K922296	IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST	Jul 14, 1992	Substantially Equivalent	Ampcor, Inc.
K920221	HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY	Mar 13, 1992	Substantially Equivalent	Akers Research Corp.
K902510	CARDS O.S. MONO	Jul 16, 1990	Substantially Equivalent	Pacific Biotech, Inc.
K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	Jun 28, 1990	Substantially Equivalent	Trinity Laboratories, Inc.
K900625	MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET	Feb 26, 1990	Substantially Equivalent	Armkel, LLC
K896926	DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS	Jan 26, 1990	Substantially Equivalent	Quidel Corp.
K895891	DETECTADOT SYSTEM 2000 HETEROPHILE TEST	Oct 31, 1989	Substantially Equivalent	Gull Laboratories, Inc.
K895765	LEECO PREVIEW(R) EBV (EIA)	Oct 31, 1989	Substantially Equivalent	Leeco Diagnostics, Inc.
K894975	IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST	Sep 13, 1989	Substantially Equivalent	General Biometrics, Inc.
K894793	MONODEX	Aug 21, 1989	Substantially Equivalent	Cenogenics Corp.
K893737	DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST	Jun 16, 1989	Substantially Equivalent	Quidel Corp.
K890991	MONO-CUBE(TM)	Mar 16, 1989	Substantially Equivalent	Difco Laboratories, Inc.
K890041	V-TREND TARGET IM TEST	Jan 23, 1989	Substantially Equivalent	Texas Immunology, Inc.
K883709	MODIFICATION OF MONO-PLUS(TM)	Dec 20, 1988	Substantially Equivalent	Armkel, LLC
K884007	CARDS(TM) MONO	Nov 18, 1988	Substantially Equivalent	Pacific Biotech, Inc.
K883540	OXOID INFECTIOUS MONONUCLEOSIS KIT	Oct 19, 1988	Substantially Equivalent	Unipath , Ltd.
K883004	MONO-PLUS(TM)	Aug 04, 1988	Substantially Equivalent	Wampole Laboratories
K881247	MONO-PHILE	Apr 07, 1988	Substantially Equivalent	Bio Diagnostic Systems, Inc.
K880399	V-TREND IM DRY-SPOT TEST	Feb 17, 1988	Substantially Equivalent	Texas Immunology, Inc.
K880148	INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST	Feb 10, 1988	Substantially Equivalent	Ampcor, Inc.
K874678	I.M.N. LATEX	Dec 14, 1987	Substantially Equivalent	Biokit USA, Inc.
K873297	DIFFERENTIAL I.M. SCREENING TEST	Dec 14, 1987	Substantially Equivalent	Sclavo, Inc.
K872032	VENTRESCREEN (TM) MONO	Jun 29, 1987	Substantially Equivalent	Ventrex Laboratories, Inc.
K864207	DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO	Dec 03, 1986	Substantially Equivalent	Gamma Biologicals, Inc.
K862008	MONO-LATEX (TM) SLIDE TEST	Jul 03, 1986	Substantially Equivalent	Armkel, LLC
K861452	MONOSTAR SYSTEM: IM LATEX TEST	May 13, 1986	Substantially Equivalent	U.S. Health Resources Corp.
K861016	GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS	Apr 18, 1986	Substantially Equivalent	Gamma Biologicals, Inc.
K853144	CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036	Oct 16, 1985	Substantially Equivalent	Preco, Inc.
K853105	IMMUNO-IM	Sep 03, 1985	Substantially Equivalent	Immunostics Co., Inc.
K853388	MONOSTICON UNI-DOT	Aug 22, 1985	Substantially Equivalent	Organon, Inc.
K844289	SERIES I/S INFECTIONS	Nov 19, 1984	Substantially Equivalent	American Dade
K841863	MONO-TEC	Jun 13, 1984	Substantially Equivalent	Medilab Corp.
K840822	LEAP MONO TEST KIT	Apr 05, 1984	Substantially Equivalent	Cooper Biomedical, Inc.
K834345	IM-CHECK	Feb 10, 1984	Substantially Equivalent	Diagnostic Technology, Inc.
K830531	MONO SCREENING TEST	Mar 17, 1983	Substantially Equivalent	Tago, Inc.
K821386	SERO/TEX MONO TEST	Jul 02, 1982	Substantially Equivalent	Texas Immunology, Inc.
K812540	CORDIA IM	Sep 24, 1981	Substantially Equivalent	Cordis Corp.
K791455	AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS	Dec 31, 1979	Substantially Equivalent	Volu Sol Medical Industries
K771397	MONOSTICON TEST	Aug 22, 1977	Substantially Equivalent	Organon, Inc.
K760040	TEST, MONO., CARD (MACRO-VUE)	Aug 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic