Product Code: LFX FDA class 2 21 CFR 866.3510

Enzyme Linked Immunoabsorbent Assay, Rubella

Microbiology

An enzyme-linked immunosorbent assay (ELISA) for rubella is a laboratory diagnostic test used to detect rubella-specific antibodies in serum, supporting the assessment of immune status and the diagnosis of current or past rubella infection, which is particularly important for women of childbearing age. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LFX and is regulated under 21 CFR 866.3510 within the Microbiology specialty. This device is eligible for third-party review.

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Basic Information

Product Code: LFX
Device Class: FDA class 2
Regulation Number: 866.3510
Medical Specialty: Microbiology
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 94 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250588	Access Rubella IgG	Nov 17, 2025	Substantially Equivalent	Beckman Coulter, Inc.
K243168	Alinity i Rubella IgG	Jun 20, 2025	Substantially Equivalent	Abbott Laboratories
K122397	LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM	Sep 06, 2012	Substantially Equivalent	DiaSorin, Inc.
K093101	MAGO 4S	Jan 21, 2011	Substantially Equivalent	Diamedix Corp.
K092587	BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM	Dec 03, 2010	Substantially Equivalent	Bio-Rad Laboratories
K092322	ELECSYS RUBELLA IGM IMMUNOASSAY	Mar 12, 2010	Substantially Equivalent	Roche Diagnostics
K080766	VIDAS RUB IGG	Dec 23, 2008	Substantially Equivalent	bioMerieux, Inc.
K072617	ELECSYS RUBELLA IGG IMMUNOASSAY	Dec 05, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K073390	DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS	Nov 21, 2008	Substantially Equivalent	DiaSorin, Inc.
K063186	ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM	Mar 21, 2007	Substantially Equivalent	Zeus Scientific, Inc.
K063143	VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS	Dec 26, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K031606	ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY	Jun 20, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K012077	IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6	Jan 10, 2002	Substantially Equivalent	Diagnostic Products Corp.
K010668	BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY	Jul 05, 2001	Substantially Equivalent	Bayer Corp.
K003412	ADVIA CENTAUR RUBELLA IGG ASSAY	Apr 13, 2001	Substantially Equivalent	Bayer Corp.
K001875	DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM	Aug 21, 2000	Substantially Equivalent	Diamedix Corp.
K993291	COPALIS RUBELLA IGM	Feb 10, 2000	Substantially Equivalent	DiaSorin, Inc.
K984180	THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM	Jul 20, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K983805	THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO	May 26, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K981729	IS-RUBELLA IGG TEST SYSTEM	Jan 28, 1999	Substantially Equivalent	Diamedix Corp.
K982078	IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)	Dec 11, 1998	Substantially Equivalent	Diagnostic Products Corp.
K982281	SERAQUEST RUBELLA IGM	Oct 16, 1998	Substantially Equivalent	Quest Intl., Inc.
K971304	QUANTA LITE REBELLA IGG	Jan 02, 1998	Substantially Equivalent	Inova Diagnostics, Inc.
K963613	IMMULITE RUBELLA IGG	Apr 02, 1997	Substantially Equivalent	Diagnostic Products Corp.
K952721	RUBASCAN CARD TEST	Dec 20, 1996	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K960367	INCSTAR RUBELLA IGG ELISA ASSAY	Oct 24, 1996	Substantially Equivalent	Incstar Corp.
K960358	INCSTAR RUBELLA IGG FAST ELISA ASSAY	Oct 24, 1996	Substantially Equivalent	Incstar Corp.
K954045	AXSYM RUBELLA IGG ANTIBODY ASSAY	Sep 24, 1996	Substantially Equivalent	Abbott Laboratories
K961053	SERAQUEST RUBELLA IGG	Sep 04, 1996	Substantially Equivalent	Quest Intl., Inc.
K951541	IMX RUBELLA IGG	Jul 16, 1996	Substantially Equivalent	Abbott Laboratories
K954318	ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY	May 14, 1996	Substantially Equivalent	Abbott Laboratories
K951359	RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE	Apr 15, 1996	Substantially Equivalent	Bayer Corp.
K954687	ACCESS RUBELLA IGG	Apr 09, 1996	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K950227	RUBELISA (RUBESTAT)	Aug 15, 1995	Substantially Equivalent	Bio-Whittaker, Inc., A Cambrex Co.
K941624	RUBELLA IGG ELISA TEST	Aug 04, 1995	Substantially Equivalent	Gull Laboratories, Inc.
K931059	IMX RUBELLA IGM ANTIBODY ASSAY	Dec 19, 1994	Substantially Equivalent	Abbott Laboratories
K925355	BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST	Jul 12, 1994	Substantially Equivalent	Princeton Biomedix
K922586	BARTELS RUBELLA IGG EIA	Sep 17, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922581	BARTELS RUBELLA IGM EIA	Sep 17, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K921573	RUBELLA IGM	Aug 27, 1992	Substantially Equivalent	Clark Laboratories, Inc.
K914028	RUBELLA IGM ELISA TEST SYSTEM	Apr 22, 1992	Substantially Equivalent	Zeus Scientific, Inc.
K915870	OPUS RUBELLA TEST SYSTEM	Mar 23, 1992	Substantially Equivalent	Pb Diagnostics, Inc.
K915893	RUBELLA IGG ELISA TEST	Mar 04, 1992	Substantially Equivalent	Gull Laboratories, Inc.
K914420	ELISA RUBELLA IGM	Dec 27, 1991	Substantially Equivalent	Sclavo, Inc.
K911444	RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM	Aug 30, 1991	Substantially Equivalent	Wampole Laboratories
K911393	RUBENOSTIKA IGG MICROELISA SYSTEM	Apr 29, 1991	Substantially Equivalent	Organon Teknika Corp.
K905079	ORTHO RUBELLA-M ANTIBODY ELISA TEST	Dec 04, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K904084	RUBELLA IGM ELISA TEST	Dec 04, 1990	Substantially Equivalent	Gull Laboratories, Inc.
K903308	TRANSTAT-CMV(TM)	Dec 04, 1990	Substantially Equivalent	Ab Sangtec Medical
K902571	MODIFICATION OF SEROCARD RUBELLA IGG TEST	Sep 05, 1990	Substantially Equivalent	Disease Detection International, Inc.
K902925	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)	Aug 09, 1990	Substantially Equivalent	Vitek Systems, Inc.
K902793	RUBELLA IGG	Jul 31, 1990	Substantially Equivalent	Pharmacia Diagnostics, Inc.
K901635	RUBELLA IGG ELISA TEST	Jun 28, 1990	Substantially Equivalent	Gull Laboratories, Inc.
K896479	ORTHO* RUBELLA-G ANTIBODY ELISA TEST	Dec 29, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K894946	PLATELIA RUBELLA IGG KIT	Dec 21, 1989	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K894546	IMMUNODOT RUBELLA TEST	Oct 16, 1989	Substantially Equivalent	General Biometrics, Inc.
K892202	DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST	Sep 13, 1989	Substantially Equivalent	Gull Laboratories, Inc.
K894544	BIOTROL RUB-E.I.A. TEST G	Aug 30, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K885300	CAPTIA(R) RUBELLA-M	Aug 15, 1989	Substantially Equivalent	Mercia Diagnostics , Ltd.
K883924	CAPTIA(R) RUBELLA-G	Aug 15, 1989	Substantially Equivalent	Mercia Diagnostics , Ltd.
K891783	RUBELLA ELISA TEST SYSTEM	Aug 03, 1989	Substantially Equivalent	Zeus Scientific, Inc.
K885297	IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY	Jun 23, 1989	Substantially Equivalent	Abbott Laboratories
K885295	IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY	Jun 23, 1989	Substantially Equivalent	Abbott Laboratories
K892051	RUBELLA-CUBE(TM)	Jun 08, 1989	Substantially Equivalent	Difco Laboratories, Inc.
K884247	MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT	Apr 10, 1989	Substantially Equivalent	Disease Detection International, Inc.
K890091	MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT	Feb 03, 1989	Substantially Equivalent	Labsystems, Inc.
K884898	IMMUNODOT TORCH TEST RUBELLA	Feb 03, 1989	Substantially Equivalent	General Biometrics, Inc.
K885082	IMMUNODOT RUBELLA TEST	Feb 02, 1989	Substantially Equivalent	General Biometrics, Inc.
K884617	ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY	Feb 02, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K882999	RUBENOSTIKA(TM) IGM MICROELISA SYSTEM	Jan 31, 1989	Substantially Equivalent	Organon Teknika Corp.
K883182	FIAGEN RUBELLA IGG	Oct 31, 1988	Substantially Equivalent	Cyberfluor, Inc.
K883778	RUBELLA IGM MICROASSAY	Oct 25, 1988	Substantially Equivalent	Diamedix Corp.
K882475	AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200	Oct 06, 1988	Substantially Equivalent	Amersham Corp.
K881243	RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201	Apr 04, 1988	Substantially Equivalent	Labsystems, Inc.
K875368	THE DDI SERODOT RUBELLA IGG TEST KIT	Mar 23, 1988	Substantially Equivalent	Disease Detection International, Inc.
K873780	MODIFICATION RUBELLA IGM EIA TEST KIT	Oct 15, 1987	Substantially Equivalent	Labsystems, Inc.
K873088	VIRGO(TM) RUBELLA IGG ELISA	Sep 09, 1987	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K872071	CHROMOTITRE E.I.A. RUBELLA IGG	Aug 24, 1987	Substantially Equivalent	Ismunit Istituto Immunologico Intaliano
K864602	RUBELLA MICROASSAY	Apr 14, 1987	Substantially Equivalent	Diamedix Corp.
K864315	CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY	Feb 02, 1987	Substantially Equivalent	Cytotech, Inc.
K862431	RUBELLA IGM EIA TEST KIT	Aug 08, 1986	Substantially Equivalent	Labsystems, Inc.
K860145	RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540	Jul 14, 1986	Substantially Equivalent	Clinical Sciences, Inc.
K853696	RUBELLA IGG EIA TEST KIT	Jun 17, 1986	Substantially Equivalent	Labsystems, Inc.
K861282	MUREX SUDS RUBELLA	Jun 13, 1986	Substantially Equivalent	Murex Corp.
K854618	CORDOT R	May 01, 1986	Substantially Equivalent	Cordis Corp.
K853069	TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT	Jan 01, 1986	Substantially Equivalent	Hybritech, Inc.
K841200	RUBELLA IGG ANTIBODY ELISA TEST SYS	May 21, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K822342	ORTHO RUBELLA ELISA TEST SYSTEM	Mar 17, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K821804	RUBELLA RQ BIO-ENZABEAD KIT	Sep 14, 1982	Substantially Equivalent	Litton Bionetics
K813493	ENZYGNOST TM RUBELLA IGM	Mar 04, 1982	Substantially Equivalent	Calbiochem-Behring Corp.
K812787	EIA RUBELLA	Nov 27, 1981	Substantially Equivalent	Gilford
K803175	RUBELLA VIRUS SEROLOGICAL REAGENTS	Jan 29, 1981	Substantially Equivalent	Microbiological Research Corp.
K803133	RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL	Jan 29, 1981	Substantially Equivalent	Microbiological Research Corp.
K791746	ROTAZYME	Nov 16, 1979	Substantially Equivalent	Abbott Laboratories