Product Code: LIQ FDA class 1 21 CFR 866.3405

Enzyme Linked Immunoabsorbent Assay, Rotavirus

Microbiology

An enzyme-linked immunosorbent assay (ELISA) for rotavirus is a laboratory diagnostic test used to detect rotavirus antigens or antibodies in patient stool or serum specimens, supporting the diagnosis of rotavirus gastroenteritis, particularly in young children and immunocompromised patients. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LIQ and is regulated under 21 CFR 866.3405 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: LIQ
Device Class: FDA class 1
Regulation Number: 866.3405
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

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 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K990842	SAS ROTA TEST	Aug 09, 1999	Substantially Equivalent	Sa Scientific, Inc.
K972895	VIDAS ROTAVIRUS (RTV) ASSAY	Oct 03, 1997	Substantially Equivalent	Biomerieux Vitek, Inc.
K971585	IMMUNOCARD STAT! ROTAVIRUS	Aug 20, 1997	Substantially Equivalent	Meridian Diagnostics, Inc.
K964424	ROTAVIRUS EIA	Aug 08, 1997	Substantially Equivalent	Trinity Biotech, Inc.
K965092	VIDAS ROTAVIRUS ASSAY	May 05, 1997	Substantially Equivalent	Biomerieux Vitek, Inc.
K951208	ROTA-DAN RAPID ROTAVIRUS EIA KIT	Feb 14, 1996	Substantially Equivalent	Eldan Technologies, Ltd.
K942286	DIARLEX ROTA-ADENO	Dec 14, 1994	Substantially Equivalent	Orion Diagnostica, Inc.
K933587	IMMUNOCARD ROTAVIRUS	Feb 03, 1994	Substantially Equivalent	Meridian Diagnostics, Inc.
K932384	IDEIA(TM) ROTAVIRUS	Dec 27, 1993	Substantially Equivalent	Dako Diagnostics , Ltd.
K915137	KALLESTAD ROTAVIRUS MICROPLATE	Mar 04, 1992	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K912666	DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440	Feb 14, 1992	Substantially Equivalent	Dako Corp.
K895805	SLIDEX ROTA-KIT 2	Feb 26, 1991	Substantially Equivalent	Vitek Systems, Inc.
K884017	ROTACUBE	Jan 24, 1989	Substantially Equivalent	Difco Laboratories, Inc.
K883940	ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST	Jan 04, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K883935	ORTHO* ROTAVIRUS ANTIGEN ELISA TEST	Jan 04, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K880821	RESUBMITTED ABBOTT TESTPACK ROTAVIRUS	May 06, 1988	Substantially Equivalent	Abbott Laboratories
K874375	ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL	Dec 10, 1987	Substantially Equivalent	Abbott Laboratories
K873740	ROTASCREEN EIA	Nov 27, 1987	Substantially Equivalent	Mercia Diagnostics , Ltd.
K864811	ROTA-STAT	Aug 25, 1987	Substantially Equivalent	Intl. Diagnostic Laboratories, Ltd.
K861628	WELLCOZYME ROTAVIRUS WZ01	Jan 21, 1987	Substantially Equivalent	Wellcome Diagnostics
K861634	THE WELLCOME ROTAVIRUS LATEX TEST ZL40	Oct 29, 1986	Substantially Equivalent	Wellcome Diagnostics
K862917	PATHFINDER ROTAVIRUS CHEMILUMINESCENT	Oct 22, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K861172	ROTAVIRUS LATEX AGGLUTINATION ASSAY	Jul 01, 1986	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K860529	ROTALEX	Mar 04, 1986	Substantially Equivalent	Orion Corp.
K854129	ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS	Jan 21, 1986	Substantially Equivalent	Orion Diagnostica, Inc.
K853554	PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS	Nov 26, 1985	Substantially Equivalent	Kallestad Laboratories, Inc.
K853399	VIROGEN ROTATEST SLIDE TEST	Nov 12, 1985	Substantially Equivalent	Armkel, LLC
K852969	ROTACLONE ROTAVIRUS DIAGNOSTIC KIT	Nov 05, 1985	Substantially Equivalent	Cambridge Bioscience Corp.
K850269	MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE	Jul 18, 1985	Substantially Equivalent	Meridian Diagnostics, Inc.
K843367	ROTAVIRUS ENZYME IMMUNOASSAY	Jun 13, 1985	Substantially Equivalent	Intl. Diagnostic Laboratories, Ltd.
K841243	ENZYGNOST ROTAVIRUS AG	Oct 17, 1984	Substantially Equivalent	Behring Diagnostics, Inc.
K841319	ROTALEX LATEX AGGLUTINATION TEST	Sep 14, 1984	Substantially Equivalent	Orion Diagnostica, Inc.
K834443	ROTAVIRUS BIO-ENZABEAD SCREEN KIT	Mar 16, 1984	Substantially Equivalent	Litton Bionetics