Product Code: LKJ FDA class 2 21 CFR 866.5100

Antinuclear Antibody, Antigen, Control

Immunology

Antinuclear Antibody, Antigen, Control is an antigen and control material used in immunoassay systems designed to detect antinuclear antibodies (ANA), which serve as markers for a range of autoimmune disorders including lupus, Sjogren's syndrome, and mixed connective tissue disease. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKJ, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: LKJ
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 50 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K210902	EliA Ro52, EliA Ro60	Jul 27, 2022	Substantially Equivalent	Phadia AB
K113610	ANA-SCREEN WITH MDSS	Jul 09, 2012	Substantially Equivalent	Bio-Rad Laboratories
K082759	ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY	Apr 10, 2009	Substantially Equivalent	Phadia US, Inc.
K081104	AESKULISA ANA HEP-2, REF 30-7115US	May 02, 2008	Substantially Equivalent	Aesku Diagnostics
K041658	BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200	Dec 20, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K042416	ATHENA MULTI-LYTE ANA-II TEST SYSTEM	Oct 08, 2004	Substantially Equivalent	Zeus Scientific, Inc.
K034013	REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001	Jan 08, 2004	Substantially Equivalent	Corgenix, Inc.
K030775	AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM	May 12, 2003	Substantially Equivalent	Immuno Concepts, N.A. , Ltd.
K024232	LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113	Jan 17, 2003	Substantially Equivalent	Bio-Rad
K024218	LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114	Jan 17, 2003	Substantially Equivalent	Bio-Rad
K024223	LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116	Jan 13, 2003	Substantially Equivalent	Bio-Rad
K024226	LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116	Jan 10, 2003	Substantially Equivalent	Bio-Rad
K021257	ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)	Jun 03, 2002	Substantially Equivalent	Diagnostic Products Corp.
K021103	MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM	Apr 24, 2002	Substantially Equivalent	Zeus Scientific, Inc.
K011244	ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM	Dec 10, 2001	Substantially Equivalent	Zeus Scientific, Inc.
K993294	DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM	Oct 25, 1999	Substantially Equivalent	Diamedix Corp.
K984478	LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K984475	LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K984473	LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K984470	LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K984464	LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K961815	QUALITROL ANA CONTROL SERUM SET	Sep 27, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K954891	HYTEC AUTOIMMUNE KITS (SS-B)	Dec 26, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K954392	HYTEC AUTOIMMUNE KIT (SS-A)	Dec 26, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K954723	ENZYME IMMUNOASSAY ANA SCREENING TEST KIT	Dec 15, 1995	Substantially Equivalent	Helix Diagnostics, Inc.
K954700	ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT	Dec 15, 1995	Substantially Equivalent	Helix Diagnostics, Inc.
K932876	DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT	Nov 15, 1993	Substantially Equivalent	Shield Diagnostics, Ltd.
K931255	SYNELISA CENP-B ANTIBODIES	Sep 24, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K932679	RHEUMELISA II HISTONE ANTIBODY TEST KIT	Aug 23, 1993	Substantially Equivalent	Biowhittaker Molecular Applications, Inc.
K932302	SYLNELISA HISTONE ANTIBODIES	Aug 23, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K921132	SYN ELISA DSDNA ANTIBODIES	Dec 01, 1992	Substantially Equivalent	Elias U.S.A., Inc.
K914454	THE THERATEST EL-ANA PROFILES	May 22, 1992	Substantially Equivalent	Theratest Laboratories, Inc.
K913342	AUTOSTAT(TM) ANTI-DSNA	May 01, 1992	Substantially Equivalent	Cogent Diagnotics , Ltd.
K920150	ENCORE SCL-70	Mar 18, 1992	Substantially Equivalent	Clark Laboratories, Inc.
K914550	ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM	Feb 11, 1992	Substantially Equivalent	Diagnostic Resources, Inc.
K912291	DISTAT ANTI-SCL-70 KIT	Jul 30, 1991	Substantially Equivalent	Shield Diagnostics, Ltd.
K894411	SERATEST ENA [SCL-70] KIT	Aug 02, 1989	Substantially Equivalent	Hemagen Diagnostics, Inc.
K893896	QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA	Jul 14, 1989	Substantially Equivalent	Biostar Medical Products, Inc.
K893897	SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM	Jun 23, 1989	Substantially Equivalent	Biostar Medical Products, Inc.
K885224	ANA-5 AUTOANTIBODY PROFILE KIT	Apr 14, 1989	Substantially Equivalent	Autoimmunity Diagnostics Corp.
K883949	ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)	Oct 27, 1988	Substantially Equivalent	Immco Diagnostics, Inc.
K883883	ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)	Oct 27, 1988	Substantially Equivalent	Immco Diagnostics, Inc.
K882740	ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY	Sep 22, 1988	Substantially Equivalent	Lipogen, Inc.
K874115	NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)	Nov 04, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K873249	ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS	Sep 22, 1987	Substantially Equivalent	Cytotech, Inc.
K864668	ANA TEST KIT	Mar 12, 1987	Substantially Equivalent	Val Tech Diagnostics, Inc.
K862313	KALLESTAD SM/RNP TEST REAGENT	Aug 06, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K842563	SERATEST DNA DETERMINATION	Oct 25, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K842484	LEAP LE TEST KIT	Jul 11, 1984	Substantially Equivalent	Cooper Biomedical, Inc.
K831463	ANA-CHECK	Jun 08, 1983	Substantially Equivalent	Diagnostic Technology, Inc.