Product Code: DHN FDA class 2 21 CFR 866.5100

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Immunology

The Antinuclear Antibody Indirect Immunofluorescent Antigen and Control is a diagnostic reagent used in indirect immunofluorescence assays to detect antinuclear antibodies (ANA) in patient serum, which are markers associated with autoimmune diseases such as lupus, Sjogren's syndrome, and rheumatoid arthritis. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5100 within the Immunology specialty. The device is eligible for third-party 510(k) review.

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510(k)s

110

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DHN
Device Class: FDA class 2
Regulation Number: 866.5100
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 110 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201956	Zeus IFA ANA HEp-2 Test System, Zeus dIFine	Apr 29, 2022	Substantially Equivalent	Zeus Scientific, Inc.
K172745	ImmuGlo HEp-2 Elite IFA	Jun 05, 2018	Substantially Equivalent	Immco Diagnostics, Inc.
K153117	AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM	Jul 28, 2016	Substantially Equivalent	Aesku Systems GmbH&Co.Kg
K160265	Image Navigator by Immuno Concepts	Jun 17, 2016	Substantially Equivalent	Immuno Concepts, N.A. , Ltd.
K141827	EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE	Apr 17, 2015	Substantially Equivalent	Euroimmun Us, Inc.
K150155	NOVA Lite DAPI ANA Kit	Apr 08, 2015	Substantially Equivalent	Inova Diagnostics, Inc.
K131791	IFA 40: HEP-20-10	Feb 26, 2014	Substantially Equivalent	Euroimmun US
K120889	AESKUSLIDES ANA HEP-2	Oct 15, 2012	Substantially Equivalent	Aesku Diagnostics
K070763	EUROIMMUN ANA IFA: HEP-20-10	May 22, 2007	Substantially Equivalent	Euroimmun Us, LLC
K042680	RHIGENE HEP-ANA TEST SYSTEM	Nov 19, 2004	Substantially Equivalent	Corgenix, Inc.
K024220	LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130	Jan 17, 2003	Substantially Equivalent	Bio-Rad
K024230	LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024229	LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024227	LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024225	LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024224	LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024222	LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024221	LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024217	LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108	Jan 15, 2003	Substantially Equivalent	Bio-Rad
K024231	LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118	Jan 13, 2003	Substantially Equivalent	Bio-Rad
K022800	VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM	Nov 25, 2002	Substantially Equivalent	Hyperion, Inc.
K013213	HYPERION VISIQUANT ANA TEST KIT	Jun 04, 2002	Substantially Equivalent	Hyperion, Inc.
K012163	POLYTITER SYSTEM	Aug 20, 2001	Substantially Equivalent	Polymedco, Inc.
K001556	HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY	Aug 21, 2000	Substantially Equivalent	The Binding Site, Ltd.
K990915	INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY	Apr 21, 1999	Substantially Equivalent	Stellar Bio Systems, Inc.
K984400	LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202	Dec 18, 1998	Substantially Equivalent	Bio-Rad
K984399	LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204	Dec 18, 1998	Substantially Equivalent	Bio-Rad
K984398	LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201	Dec 18, 1998	Substantially Equivalent	Bio-Rad
K984397	LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203	Dec 18, 1998	Substantially Equivalent	Bio-Rad
K983924	HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO	Dec 18, 1998	Substantially Equivalent	Immuno Concepts, Inc.
K972145	HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM	Feb 24, 1998	Substantially Equivalent	Immuno Concepts, Inc.
K970198	IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES	Feb 20, 1997	Substantially Equivalent	Scimedx Corp.
K964165	MICRO21 WITH NDNA	Jan 03, 1997	Substantially Equivalent	Triangle Biomedical Sciences, Inc.
K962276	HEMAGEN ENA DSDNA KIT (EIA METHOD)	Dec 05, 1996	Substantially Equivalent	Hemagen Diagnostics, Inc.
K950979	HEP-2000 COLORZYME ANA-RO TEST SYSTEM	Jun 01, 1995	Substantially Equivalent	Immuno Concepts, Inc.
K944096	HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM	Nov 21, 1994	Substantially Equivalent	Immuno Concepts, Inc.
K926114	HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM	May 20, 1993	Substantially Equivalent	Tissue Culture Biotec, Inc.
K912292	DIASTAT ANTI-JO-1 KIT	Jul 30, 1991	Substantially Equivalent	Shield Diagnostics, Ltd.
K902139	HEMAGEN ENA [JO-I] KIT	May 18, 1990	Substantially Equivalent	Hemagen Diagnostics, Inc.
K901596	NOVA LITE(TM) ANA KSL	May 02, 1990	Substantially Equivalent	Inova Diagnostics, Inc.
K901595	NOVA LITE(TM) ANA MK	Apr 26, 1990	Substantially Equivalent	Inova Diagnostics, Inc.
K897025	ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM	Jan 02, 1990	Substantially Equivalent	Zeus Scientific, Inc.
K894659	ANA ANTISERA CONTROL KIT	Sep 21, 1989	Substantially Equivalent	Lipogen, Inc.
K884400	ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)	Nov 04, 1988	Substantially Equivalent	Immco Diagnostics, Inc.
K880742	NOVA LITE(TM) DSDNA	Mar 25, 1988	Substantially Equivalent	Inova Diagnostics, Inc.
K874873	COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1	Feb 10, 1988	Substantially Equivalent	Diagnostic Products Corp.
K872845	BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM	Aug 17, 1987	Substantially Equivalent	Bion Ent., Ltd.
K872560	ANTI-DNP MICROASSAY	Jul 21, 1987	Substantially Equivalent	Diamedix Corp.
K871801	CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT	Jun 09, 1987	Substantially Equivalent	Cytotech, Inc.
K871144	TANGENT SYSTEM(TM) ANA PROFILE TEST KIT	Apr 29, 1987	Substantially Equivalent	Vitrotec Laboratories, Inc.
K871395	DUAL SUBSTRATE ANA	Apr 20, 1987	Substantially Equivalent	Val Tech Diagnostics, Inc.
K870458	HISTONES EIA DIAGNOSTIC KIT	Mar 17, 1987	Substantially Equivalent	Biohytech International, Inc.
K870732	RAT LIVER NUCLEI TEST SYSTEM	Mar 10, 1987	Substantially Equivalent	Val Tech Diagnostics, Inc.
K863717	ANTI-DNA MICROASSAY	Oct 24, 1986	Substantially Equivalent	Diamedix Corp.
K862821	CAPPEL DIAGNOSTICS ANA KIT	Aug 15, 1986	Substantially Equivalent	Cappel Diagnostics, Inc.
K860183	AFT-HEP SYSTEM	Feb 26, 1986	Substantially Equivalent	Behring Diagnostics, Inc.
K854314	FANA 60	Dec 16, 1985	Substantially Equivalent	American Bio-Reagents, Inc.
K852033	SS-A(RO) & SS-B(LA) ANTIBODY ASSAY	Jun 21, 1985	Substantially Equivalent	Meloy Laboratories, Inc.
K851369	ANTINUCLEAR ANTIBODY TEST KIT	May 15, 1985	Substantially Equivalent	Modern Diagnostics, Inc.
K842991	AUTOFLUOR V SYSTEM	Mar 14, 1985	Substantially Equivalent	Tech America Diagnostics
K844678	MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL	Jan 04, 1985	Substantially Equivalent	Meloy Laboratories, Inc.
K843225	COLORZYME NDNA TEST SYSTEM	Nov 01, 1984	Substantially Equivalent	Immuno Concepts, Inc.
K841984	AUTOFLOUR III SYSTEM	Nov 01, 1984	Substantially Equivalent	Tech America Diagnostics
K843347	RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON	Oct 05, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K842183	ADP ANA IFA TEST	Jun 22, 1984	Substantially Equivalent	Apple Diagnostic Products
K841776	ANA SENSITIVITY/SPECIFICITY CONTROL	Jun 22, 1984	Substantially Equivalent	Behring Diagnostics, Inc.
K841127	VIRGO REAGENTS INDIRECT FLUORSCENT	Apr 25, 1984	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K834241	ANA APPLELISA	Apr 04, 1984	Substantially Equivalent	Apple Diagnostic Products
K833119	AUTOIMMUNE TEST 1/2/3 SYSTEM	Nov 21, 1983	Substantially Equivalent	Atlantic Antibodies
K832383	IDT ANA STIQ ASSAY	Aug 31, 1983	Substantially Equivalent	Intl. Diagnostic Technology
K831408	DNA FLOR	Jul 28, 1983	Substantially Equivalent	Medastat Scientific Corp.
K831054	ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB	Apr 27, 1983	Substantially Equivalent	Immuno-Products Industries
K830214	AFT SYSTEM III	Mar 09, 1983	Substantially Equivalent	Calbiochem-Behring Corp.
K822681	ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)	Dec 13, 1982	Substantially Equivalent	Amico Lab, Inc.
K822682	ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K	Dec 03, 1982	Substantially Equivalent	Amico Lab, Inc.
K823055	FLOUROSET IMMUNOFLUORESCENT ANTIBODY	Nov 05, 1982	Substantially Equivalent	Immulok, Inc.
K820945	SERA FOR ANTINUCLEAR ANTIBODIES	Oct 26, 1982	Substantially Equivalent	Centers for Disease Control and Prevention
K822397	ANA HEP-2 FLUORO-KIT	Sep 21, 1982	Substantially Equivalent	Clinical Sciences, Inc.
K822607	ANTINUCLEAR ANTOBODY CELL SUBSTRATE	Sep 17, 1982	Substantially Equivalent	Immulok, Inc.
K820265	ANA TEST (MOUSE LIVER SUBSTRATE)	Feb 12, 1982	Substantially Equivalent	Meloy Laboratories, Inc.
K813592	QUANTAFLUOR FLUORESCENT TEST REAGENTS	Jan 18, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K812314	CRITHIDNA ANTI-DNA TEST KIT	Sep 01, 1981	Substantially Equivalent	Antibodies, Inc.
K811714	HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT	Jul 10, 1981	Substantially Equivalent	Scripps-Miles, Inc.
K810985	ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT	May 01, 1981	Substantially Equivalent	Immuno-Products Industries
K811022	ANA TEST KIT	Apr 23, 1981	Substantially Equivalent	Immuno-Diagnostic Products, Inc.
K810301	CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST	Feb 25, 1981	Substantially Equivalent	Immuno Concepts, Inc.
K810081	SCRIPPSERA ANA REFERENCE CONTROL SERA	Feb 09, 1981	Substantially Equivalent	Scripps-Miles, Inc.
K802299	K/K (ASMA/ANA) UNIVERSAL BIOPAK	Jan 29, 1981	Substantially Equivalent	Bioware Products
K803276	ANA-IFA TEST SYSTEM	Jan 26, 1981	Substantially Equivalent	Immuno Concepts, Inc.
K802527	TEST KIT FOR DETECTION OF ANTINUCLEAR	Jan 05, 1981	Substantially Equivalent	Bartels & Stout, Inc.
K801046	ANATON	May 14, 1980	Substantially Equivalent	Armkel, LLC
K792184	LAB-TEK ANA TEST KIT	Nov 30, 1979	Substantially Equivalent	Miles Laboratories, Inc.
K791928	ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT	Nov 13, 1979	Substantially Equivalent	Keith E. Abbott
K791995	ANTI NUCLEAR ANTIBODY TEST	Oct 30, 1979	Substantially Equivalent	Meda Stat Diagnostics, Inc.
K791493	ANTI-NUCLEAR ANTIBODY TEST	Sep 24, 1979	Substantially Equivalent	Meloy Laboratories, Inc.
K790280	AUTOANTIBODY REAGENTS, AFT SYSTEM II	Apr 23, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K790252	ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI	Mar 15, 1979	Substantially Equivalent	Meloy Laboratories, Inc.
K782048	TEST KIT, IIF-ANA	Jan 17, 1979	Substantially Equivalent	Medica Corp.
K782041	FIAX TEST KIT	Jan 03, 1979	Substantially Equivalent	Idt, A Division of Whittaker M.A. Bioproducts
K780899	FLUORESCENT ANTI-NATIVE DNA TEST	Sep 07, 1978	Substantially Equivalent	Kallestad Laboratories, Inc.
K780178	TEST SYS. FOR NDNA ANTIBODY DETERM.	Feb 13, 1978	Substantially Equivalent	Zeus Scientific, Inc.
K780161	IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER	Feb 07, 1978	Substantially Equivalent	Zeus Scientific, Inc.
K772219	FIAX TEST FOR ANTI-RUBELLA ANTIBODY	Jan 20, 1978	Substantially Equivalent	Idt, A Division of Whittaker M.A. Bioproducts
K771376	IFA ANTI-NDNA	Oct 18, 1977	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K771064	ANA TEST	Jun 24, 1977	Substantially Equivalent	Gull Laboratories, Inc.
K770057	NDNA IMMUNOPATH FLUORO-KIT	Apr 05, 1977	Substantially Equivalent	Clinical Sciences, Inc.
K760681	INDIRECT FLUORESCENT (IFA-ANA)	Oct 21, 1976	Substantially Equivalent	Wampole Laboratories
K760206	TEST, DETECTION, ANTINUCLEAR ANTIBODIES	Aug 03, 1976	Substantially Equivalent	Intl. Diagnostic Technology
K760209	ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP	Jul 26, 1976	Substantially Equivalent	Zeus Scientific, Inc.
K760153	TEST, (IVDP) ANTINUCLEAR ANTIBODY	Jul 20, 1976	Substantially Equivalent	Zeus Scientific, Inc.