Product Code: LJM FDA class 2 21 CFR 866.5100

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Immunology

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls are enzyme-labeled antigens and control materials used in immunoassay systems to detect antinuclear antibodies (ANA), which are markers associated with autoimmune conditions such as systemic lupus erythematosus. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LJM, regulated under 21 CFR 866.5100, and is reviewed within the Immunology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

112

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LJM
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 112 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K182353	EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay	Nov 27, 2018	Substantially Equivalent	Phadia AB
K151559	ImmuLisa Enhanced Centromere Antibody ELISA	Mar 11, 2016	Substantially Equivalent	Immco Diagnostics, Inc.
K140493	ELIA SCL-70S IMMUNOASSAY	Oct 30, 2014	Substantially Equivalent	Phadia GmbH
K123880	QUANTA FLASH CENTROMERE	Feb 07, 2014	Substantially Equivalent	Inova Diagnostics, Inc.
K131330	GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT	Jan 28, 2014	Substantially Equivalent	Gold Standard Diagnostics
K131185	ANA SCREEN ELISA (IGG)	Jul 15, 2013	Substantially Equivalent	Euroimmun US
K083188	VARELISA RECOMBI ANA SCREEN, MODEL 12 596	Mar 13, 2009	Substantially Equivalent	Phadia US, Inc.
K050967	VARELISA RECOMBI CTD SCREEN, MODEL 13096	Jun 28, 2005	Substantially Equivalent	Sweden Diagnostics (Germany) GmbH
K050625	VARELISA RECOMBI ANA PROFILE, MODEL 18496	Apr 26, 2005	Substantially Equivalent	Sweden Diagnostics (Germany) GmbH
K041102	IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA	Oct 26, 2004	Substantially Equivalent	Immco Diagnostics, Inc.
K040953	AESKULISA ANA HEP-2	Jun 23, 2004	Substantially Equivalent	Aesku, Inc.
K040810	VARELISA HISTONE ANTIBODIES, MODEL 16496	May 14, 2004	Substantially Equivalent	Pharmacia Deutschland GmbH
K040291	EL-ANA PROFILES: ANTI-CHROMATIN	Mar 11, 2004	Substantially Equivalent	Theratest Laboratories, Inc.
K040200	MESACUP-2 TEST CENP-B	Mar 04, 2004	Substantially Equivalent	Rhigene, Inc.
K030929	ANA DETECT	May 02, 2003	Substantially Equivalent	Orgentec Diagnostika GmbH
K024031	THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE	Feb 06, 2003	Substantially Equivalent	Theratest Laboratories, Inc.
K022018	RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560	Jul 05, 2002	Substantially Equivalent	Rhigene, Inc.
K004019	ANA EIA DIAGNOSTIC TEST KIT	Feb 15, 2001	Substantially Equivalent	The Binding Site, Ltd.
K003959	QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA	Jan 22, 2001	Substantially Equivalent	Inova Diagnostics, Inc.
K002559	EL-ANA PROFILES-2K1	Sep 12, 2000	Substantially Equivalent	Theratest Laboratories, Inc.
K000880	THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE	May 22, 2000	Substantially Equivalent	Zeus Scientific, Inc.
K000879	THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE	May 22, 2000	Substantially Equivalent	Zeus Scientific, Inc.
K000934	MDI SCL-70 TEST	Apr 07, 2000	Substantially Equivalent	Micro Detect, Inc.
K994071	RHIGENE ANA ELISA TEST SYSTEM	Jan 18, 2000	Substantially Equivalent	Rhigene, Inc.
K993636	MDI SS-A TEST	Jan 10, 2000	Substantially Equivalent	Micro Detect, Inc.
K993635	MDI SM/RNP TEST	Jan 10, 2000	Substantially Equivalent	Micro Detect, Inc.
K993109	VARELISA RECOMBI ANA PROFILE	Nov 12, 1999	Substantially Equivalent	Pharmacia & Upjohn Co.
K993108	VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96	Nov 12, 1999	Substantially Equivalent	Pharmacia & Upjohn Co.
K992041	RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11	Jul 23, 1999	Substantially Equivalent	Immuno Concepts, Inc.
K983655	AUTOSTAT II ANA SCREEN ELISA	Jan 28, 1999	Substantially Equivalent	Cogent Diagnotics , Ltd.
K983378	THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.	Nov 18, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K980810	SERAQUEST ANTI-SSA	May 12, 1998	Substantially Equivalent	Quest Intl., Inc.
K980337	DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM	May 12, 1998	Substantially Equivalent	Helix Diagnostics, Inc.
K964385	ELIAS ANA-HEP-2	Mar 06, 1997	Substantially Equivalent	Elias U.S.A., Inc.
K962450	HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE	Nov 25, 1996	Substantially Equivalent	Hycor Biomedical, Inc.
K962062	ORGENTEC ANTI-SM ELISA	Nov 18, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K962057	ORGENTEC ANTI-RNP/SM ELISA	Nov 18, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K962055	ORGENTEC ANTI-SCL 70 ELISA	Nov 15, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K962054	ORGENTEC ANTI-SS-A(RO) ELISA	Nov 15, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K962053	ORGENTEC ANTI-JO-1 ELISA	Nov 15, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K962052	ORGENTEC ABTI-SS-BB(LA) ELISA	Nov 15, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K963291	VARELISA ANA (4) PROFILE	Sep 30, 1996	Substantially Equivalent	Elias U.S.A., Inc.
K954832	ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY	Apr 18, 1996	Substantially Equivalent	Orgentec
K954829	ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY	Apr 18, 1996	Substantially Equivalent	Orgentec
K954815	ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY	Apr 18, 1996	Substantially Equivalent	Orgentec
K954814	ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY	Apr 18, 1996	Substantially Equivalent	Orgentec
K955481	THERATEST KIT (MODIFICATION)	Mar 06, 1996	Substantially Equivalent	Theratest Laboratories, Inc.
K954380	QUANTA LITE SSDNA	Feb 29, 1996	Substantially Equivalent	Inova Diagnostics, Inc.
K952490	IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM	Dec 15, 1995	Substantially Equivalent	Roche Image Analysis Systems
K954106	THERATEST LAB, INC., EL-ANASCR KIT	Nov 14, 1995	Substantially Equivalent	Theratest Laboratories, Inc.
K950716	THERATEST EL-ANA PROFILES TEST SYSTEM	Sep 26, 1995	Substantially Equivalent	Theratest Laboratories, Inc.
K951850	ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT	Jul 18, 1995	Substantially Equivalent	Helix Diagnostics, Inc.
K951798	ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT	Jul 17, 1995	Substantially Equivalent	Helix Diagnostics, Inc.
K950110	MARDX MITOCHONDRIA EIA TEST SYSTEM	May 15, 1995	Substantially Equivalent	Hogan & Hartson
K946218	MARDX ENA EIA TEST SYSTEM	May 15, 1995	Substantially Equivalent	Hogan & Hartson
K951207	VARELISA HISTONE ANTIBODIES	Apr 17, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K951205	VARELISA ANA PROFILE	Apr 17, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K951186	VARELISA ANA-4 SCREEN	Apr 17, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K943585	ANTI-HISTONE ANIBODY TEST	Jan 20, 1995	Substantially Equivalent	Immco Diagnostics, Inc.
K944173	VARELISA JO-1 ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K944172	VARELISA SCL-70 ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K944171	VARELISA CENTROMERE ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K944170	VARELISA SM ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K944169	VARELISA RO (SS-A) ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K944168	VARELISA LA (SS-B) ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K944167	VARELISA RNP-SM ANTIBODIES	Dec 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K941509	RADIAS ANA SCREEN ENZYME IMMUNOASSAY	Jun 30, 1994	Substantially Equivalent	Bio-Rad
K941409	ENA PROFILE-6 ELISA TEST SYSTEM	Jun 10, 1994	Substantially Equivalent	Zeus Scientific, Inc.
K941014	ENA SCREEN ELISA TEST SYSTEM	Jun 10, 1994	Substantially Equivalent	Zeus Scientific, Inc.
K940700	AUTOZYME SCREEN	Jun 10, 1994	Substantially Equivalent	Cambridge Life Sciences Plc.
K940253	HISTONE EIA TEST KIT	May 02, 1994	Substantially Equivalent	David A. Fuccillo, Ph.D.
K935416	RO EIA TEST KIT	May 02, 1994	Substantially Equivalent	David A. Fuccillo, Ph.D.
K935415	RNP EIA TEST KIT	May 02, 1994	Substantially Equivalent	David A. Fuccillo, Ph.D.
K935414	SM EIA TEST KIT	May 02, 1994	Substantially Equivalent	David A. Fuccillo, Ph.D.
K940641	ELIAS ANA TOTAL	Mar 25, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K935468	SYNELISA ANA TOTAL	Mar 25, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K933267	AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM	Dec 15, 1993	Substantially Equivalent	Zeus Scientific, Inc.
K932206	SYNELISA ANA PROFILE	Dec 03, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K932424	ANA PROFILE I	Aug 10, 1993	Substantially Equivalent	Apotex Scientific, Inc.
K930209	SYNELISA RO ABS / LA ABS	Jun 11, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K924248	ACCUTEX SLE LATEX TEST	Nov 02, 1992	Substantially Equivalent	J.S. Medical Assoc.
K924087	KALESTAD ANA MICROPLATE EIA	Nov 02, 1992	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K920616	DIASTAT ANTI-HISTONE KIT	Jul 14, 1992	Substantially Equivalent	Shield Diagnostics, Ltd.
K915272	HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)	Mar 17, 1992	Substantially Equivalent	Hemagen Diagnostics, Inc.
K914853	ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT	Jan 15, 1992	Substantially Equivalent	Reads Medical Products, Inc.
K910033	UBI MAGIWEL(TM) ANA QUANTITATIVE	Jan 25, 1991	Substantially Equivalent	United Biotech, Inc.
K905190	DIASTAT ENA PROFILE	Dec 07, 1990	Substantially Equivalent	Shield Diagnostics, Ltd.
K902915	ANTI-SCI-70 MICROASSAY	Sep 06, 1990	Substantially Equivalent	Diamedix Corp.
K900072	IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2	Jan 24, 1990	Substantially Equivalent	General Biometrics, Inc.
K896347	IMMUNODOT AUTOIMMUNE SCREENING PANEL 1	Dec 05, 1989	Substantially Equivalent	General Biometrics, Inc.
K895995	RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES	Oct 27, 1989	Substantially Equivalent	Lipogen, Inc.
K895994	RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES	Oct 24, 1989	Substantially Equivalent	Lipogen, Inc.
K894894	ANTI-SM MICROASSAY	Aug 24, 1989	Substantially Equivalent	Diamedix Corp.
K892421	MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST	May 09, 1989	Substantially Equivalent	Lipogen, Inc.
K874195	LA ANTIBODY TEST KIT	Mar 11, 1988	Substantially Equivalent	Lipogen, Inc.
K875246	LIPOGEN ANA TEST KIT	Feb 10, 1988	Substantially Equivalent	Lipogen, Inc.
K872839	ANTINUCLEAR ANTIBODY TEST	Oct 20, 1987	Substantially Equivalent	Cappel Diagnostics, Inc.
K870453	DS-DNA EIA DIAGNOSTIC KIT	Mar 24, 1987	Substantially Equivalent	Biohytech International, Inc.
K870457	RNP EIA DIAGNOSTIC KIT	Mar 17, 1987	Substantially Equivalent	Biohytech International, Inc.
K870456	DNP EIA DIAGNOSTIC KIT	Mar 17, 1987	Substantially Equivalent	Biohytech International, Inc.
K870455	SM EIA DIAGNOSTIC KIT	Mar 17, 1987	Substantially Equivalent	Biohytech International, Inc.
K870452	SS-DNA EIA DIAGNOSTIC KIT	Mar 17, 1987	Substantially Equivalent	Biohytech International, Inc.
K862969	ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT	Oct 24, 1986	Substantially Equivalent	Biohytech International, Inc.
K852840	ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST	Aug 01, 1985	Substantially Equivalent	Modern Diagnostics, Inc.
K852231	ANA/LITE-HEP-2 TEST SYSTEM	Jul 10, 1985	Substantially Equivalent	Immuno-Products Industries
K852230	ANA/LITE-RL TEST SYSTEM	Jul 10, 1985	Substantially Equivalent	Immuno-Products Industries
K843904	DNA STAT TEST KIT	Nov 01, 1984	Substantially Equivalent	Whittaker Bioproducts, Inc.
K843745	ADP ANA APPLEZYME	Oct 25, 1984	Substantially Equivalent	Apple Diagnostic Products
K842533	AMIZYME-ANDNA TEST KIT	Sep 20, 1984	Substantially Equivalent	Amico Lab, Inc.
K842532	AMIZYME-ANA TEST KIT	Sep 20, 1984	Substantially Equivalent	Amico Lab, Inc.
K833148	ENZYME ANA TEST SYSTEM	Nov 21, 1983	Substantially Equivalent	Immuno Concepts, Inc.
K822346	HISTIMUNE ENZYME-ANA TEST	Oct 08, 1982	Substantially Equivalent	Icl Scientific