Product Code: LRM FDA class 2 21 CFR 866.5100

Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Immunology

The Anti-DNA Antibody Enzyme-Labeled Antigen and Control is an in vitro diagnostic device used to detect antibodies against double-stranded DNA in patient serum, primarily as an aid in the diagnosis and monitoring of systemic lupus erythematosus (SLE) and other autoimmune conditions. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LRM, regulated under 21 CFR 866.5100, within 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: LRM
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 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K101319	IMMULISA DSDNA ANTIBODY ELISA	Dec 09, 2010	Substantially Equivalent	Immco Diagnostics, Inc.
K083381	EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)	Apr 15, 2009	Substantially Equivalent	Euroimmun Us, Inc.
K062183	FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT	Nov 21, 2006	Substantially Equivalent	The Binding Site, Ltd.
K040811	VARELISA SSDNA ANTIBODIES, MODEL 14896	May 13, 2004	Substantially Equivalent	Pharmacia Deutschland GmbH
K001900	ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST	Sep 11, 2000	Substantially Equivalent	Helix Diagnostics, Inc.
K000477	MDI DS-DNA TEST	Mar 01, 2000	Substantially Equivalent	Micro Detect, Inc.
K994424	DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM	Feb 18, 2000	Substantially Equivalent	Diamedix Corp.
K993727	BINDAZYME ANTI-DSDNA EIA KIT	Dec 21, 1999	Substantially Equivalent	The Binding Site, Ltd.
K984396	LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213	Dec 18, 1998	Substantially Equivalent	Bio-Rad
K983422	THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET	Nov 18, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K980391	SERAQUEST ANTI-DSDNA	Apr 24, 1998	Substantially Equivalent	Quest Intl., Inc.
K974694	IS-DSDNA TEST SYSTEM	Mar 03, 1998	Substantially Equivalent	Diamedix Corp.
K962730	HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY	Mar 07, 1997	Substantially Equivalent	Hycor Biomedical, Inc.
K952567	AUTOSTATTMII ANTI-DSDNA	Mar 04, 1997	Substantially Equivalent	Cogent Diagnotics , Ltd.
K960182	DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM	Mar 20, 1996	Substantially Equivalent	Mardx Diagnostics, Inc.
K960091	ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT	Mar 20, 1996	Substantially Equivalent	Helix Diagnostics, Inc.
K954893	HYTEC AUTOMIMMUNE KIT (DS-DNA)	Mar 20, 1996	Substantially Equivalent	Hycor Biomedical, Inc.
K953671	ORGEN TEC ANTI-DSDNA ELISA ASSAY	Nov 09, 1995	Substantially Equivalent	Orgentec
K952055	ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY	Jul 18, 1995	Substantially Equivalent	American Laboratory Products Co., Ltd.
K944334	VARELISA COMBINED DNA ANTIBODIES EIA	Apr 17, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K950031	VARELISA DSDNA ANTIBODIES (FARR VERSION)	Mar 10, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K940585	SELISA ANTI-N DNA ANTIBODIES	Jun 10, 1994	Substantially Equivalent	Cambridge Life Sciences Plc.
K923537	ENCORE DS-DNA	Dec 23, 1992	Substantially Equivalent	Clark Laboratories, Inc.
K913653	3M ANTI-DSDNA FAST TEST	Nov 07, 1991	Substantially Equivalent	3M Diagnostic Systems, Inc.
K912020	ANTI-DNA MICROASSAY	Sep 23, 1991	Substantially Equivalent	Diamedix Corp.
K902897	UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE	Jul 16, 1990	Substantially Equivalent	United Biotech, Inc.
K893036	ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)	Jun 02, 1989	Substantially Equivalent	Amersham Corp.
K874191	NDNA ANTIBODY TEST KIT	Dec 18, 1987	Substantially Equivalent	Lipogen, Inc.
K870903	IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM	May 14, 1987	Substantially Equivalent	Immunomedics, Inc.