Product Code: LFZ FDA class 2 21 CFR 866.3175

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Microbiology

An enzyme-linked immunosorbent assay (ELISA) for cytomegalovirus (CMV) is a laboratory diagnostic test used to detect CMV-specific antibodies in patient serum, supporting the diagnosis of active or past CMV infection, which is clinically significant in immunocompromised patients and during pregnancy. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LFZ and is regulated under 21 CFR 866.3175 within the Microbiology specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LFZ
Device Class: FDA class 2
Regulation Number: 866.3175
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 58 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220949	Architect CMV IgG	Oct 27, 2022	Substantially Equivalent	Abbott Laboratories
K220911	Elecsys CMV IgG	Oct 12, 2022	Substantially Equivalent	Roche Diagnostics
K181213	ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control	Jul 30, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K163569	Elecsys CMV IgM	Mar 17, 2017	Substantially Equivalent	Roche Diagnostics
K162969	LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set	Jan 06, 2017	Substantially Equivalent	DiaSorin, Inc.
K142133	ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM	Oct 24, 2014	Substantially Equivalent	Roche Diagnostics
K131605	ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY	Feb 28, 2014	Substantially Equivalent	Roche Diagnostics
K040290	DIASORIN LIAISON CMV IGM/IGG	Jun 01, 2005	Substantially Equivalent	Diasorin S.P.A
K993952	IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6	Dec 16, 1999	Substantially Equivalent	Diagnostic Products Corp.
K982485	SERAQUEST CMV IGM	Jan 13, 1999	Substantially Equivalent	Quest Intl., Inc.
K984139	THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE	Jan 11, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K983803	THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE	Dec 14, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K982027	MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY	Nov 25, 1998	Substantially Equivalent	DiaSorin, Inc.
K981163	DIAMEDIX IS-CMV IGG TEST SYSTEM	Sep 21, 1998	Substantially Equivalent	Diamedix Corp.
K971335	QUANTA LITE CMV IGG ELISA	Dec 01, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K954301	ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)	Mar 24, 1997	Substantially Equivalent	Abbott Laboratories
K944438	HEMAGEN CMV IGG KIT	Feb 20, 1997	Substantially Equivalent	Hemagen Diagnostics, Inc.
K960434	INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530	Oct 17, 1996	Substantially Equivalent	Incstar Corp.
K963084	OPUS CMV TEST SYSTEM-MODIFICATION	Oct 09, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K953943	AXSYM CMV IGG ANTIBODY ASSAY	Sep 20, 1996	Substantially Equivalent	Abbott Laboratories
K955361	INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY	Jul 22, 1996	Substantially Equivalent	Incstar Corp.
K955360	INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY	Jul 22, 1996	Substantially Equivalent	Incstar Corp.
K950672	IMMULITE CMV IGG	Jun 17, 1996	Substantially Equivalent	Diagnostic Products Corp.
K954191	SERAQUEST CMV IGG	Feb 23, 1996	Substantially Equivalent	Quest Intl., Inc.
K933389	OPUS CMV-G	Jun 28, 1994	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K922582	BARTELS CYTOMEGALOVIRUS IGG EIA	Apr 08, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K924096	CMV ELISA TEST SYSTEM	Apr 02, 1993	Substantially Equivalent	Zeus Scientific, Inc.
K920661	VIDAS CMV IGG ASSAY	Feb 12, 1993	Substantially Equivalent	Vitek Systems, Inc.
K921011	PHARMACIA CMV IGM ELISA	Jul 27, 1992	Substantially Equivalent	Pharmacia Diagnostics, Inc.
K915479	CAPTIA CMV-TA	May 04, 1992	Substantially Equivalent	Mercia Diagnostics , Ltd.
K913910	ENZYGNOST(R) ANTI-CMV IGG	Apr 28, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K913693	ENZYGNOST(R) ANTI-CMV/IGM	Feb 27, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K915892	CMV IGG ELISA TEST	Feb 14, 1992	Substantially Equivalent	Gull Laboratories, Inc.
K901485	ENZYGNOST ANTI-CMV/IGG + IGM	May 20, 1991	Substantially Equivalent	Behring Diagnostics, Inc.
K904456	CYTOMEGALOVIRUS (CMV) ELISA	Apr 03, 1991	Substantially Equivalent	Virotech, Inc.
K905078	ORTHO CMV-G ANTIBODY ELISA TEST	Dec 17, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K905077	ORTHO CMV-M ANTIBODY ELISA TEST	Dec 17, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K903807	CMV IGM ELISA TEST	Dec 17, 1990	Substantially Equivalent	Gull Laboratories, Inc.
K900474	IMX CMV IGG ANTIBODY ASSAY	Jul 27, 1990	Substantially Equivalent	Abbott Laboratories
K900473	IMX CMV IGM ANTIBODY ASSAY	Jul 27, 1990	Substantially Equivalent	Abbott Laboratories
K900796	CMV IGG ELISA TEST	May 02, 1990	Substantially Equivalent	Gull Laboratories, Inc.
K896295	CAPTIA(R) CMV-M	Mar 06, 1990	Substantially Equivalent	Mercia Diagnostics , Ltd.
K896194	CAPTIA(R) CMV-G	Mar 06, 1990	Substantially Equivalent	Mercia Diagnostics , Ltd.
K896355	CMV IGM ELISA TEST SYSTEM	Feb 27, 1990	Substantially Equivalent	Zeus Scientific, Inc.
K893230	DETECTADOT TM SYSTEM 2000 CMV IGM TEST	Dec 18, 1989	Substantially Equivalent	Gull Laboratories, Inc.
K891393	ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT	Jun 23, 1989	Substantially Equivalent	Orgenics, Ltd.
K890610	VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM	Jun 23, 1989	Substantially Equivalent	Organon Teknika Corp.
K891081	CMV ELISA TEST SYSTEM	Jun 02, 1989	Substantially Equivalent	Zeus Scientific, Inc.
K884842	CMV-CUBE(TM)	Apr 11, 1989	Substantially Equivalent	Difco Laboratories, Inc.
K884248	MODIFIED DDI SEROCARD CMV IGG TEST KIT	Apr 10, 1989	Substantially Equivalent	Disease Detection International, Inc.
K883399	UBI MAGIWEL CMV IGG QUANTITATIVE	Mar 27, 1989	Substantially Equivalent	United Biotech, Inc.
K880433	CYTOMEGALOVIRUS IGG EIA KIT	Mar 27, 1989	Substantially Equivalent	De Ferris Laboratories, Inc.
K875361	SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT	May 13, 1988	Substantially Equivalent	Disease Detection International, Inc.
K852478	ENZYGNOST + ANTI-CMV IGG TEST	Sep 16, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K832221	YBBOTT CMV TOTAL AB EIA	Oct 27, 1983	Substantially Equivalent	Abbott Laboratories
K831343	CMV RQ BIO-ENZABEAD KIT	Aug 08, 1983	Substantially Equivalent	Litton Bionetics
K830615	CYTOMEGELISA STAT	May 09, 1983	Substantially Equivalent	M.A. Bioproducts
K823123	CORDIA CMV	Dec 28, 1982	Substantially Equivalent	Cordis Corp.