Product Code: LYR FDA class 1 21 CFR 866.3110

Helicobacter Pylori

Microbiology

The Helicobacter Pylori detection device (product code LYR) is a microbiology diagnostic reagent used to identify Helicobacter pylori, a bacterium associated with peptic ulcers and gastric cancer, in patient specimens through serological or other detection methods. Regulated under 21 CFR 866.3110 and classified as a Class 1 device subject only to general controls, it falls under the Microbiology specialty and is eligible for third-party review. It is not an implant and is not life-sustaining.

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Basic Information

Product Code: LYR
Device Class: FDA class 1
Regulation Number: 866.3110
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 91 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232892	Hp Detect Stool Antigen ELISA	Dec 15, 2023	Substantially Equivalent	Biomerica, Inc.
K230901	Premier HpSA Flex (619096)	Jul 03, 2023	Substantially Equivalent	Meridian Bioscience, Inc.
K192817	Curian HpSA, Curian Analyzer	Mar 13, 2020	Substantially Equivalent	Meridian Bioscience, Inc.
K183573	Vstrip H. pylori Antigen Rapid Test	Mar 14, 2019	Substantially Equivalent	Panion & BF Biotech, Inc.
K182559	PREMIER Platinum HpSA PLUS	Nov 05, 2018	Substantially Equivalent	Meridian Bioscience, Inc.
K181464	LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set	Aug 31, 2018	Substantially Equivalent	DiaSorin, Inc.
K181400	H. PYLORI CHEK	Aug 21, 2018	Substantially Equivalent	Techlab, Inc.
K181379	H. PYLORI QUIK CHEK	Aug 21, 2018	Substantially Equivalent	Techlab, Inc.
K161139	LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set	Jul 22, 2016	Substantially Equivalent	DiaSorin, Inc.
K153661	ImmunoCard STAT! HpSA	Mar 14, 2016	Substantially Equivalent	Meridian Bioscience, Inc.
K151935	Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only	Aug 12, 2015	Substantially Equivalent	Alere San Diego, Incorporated
K141133	VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II	Jul 09, 2015	Substantially Equivalent	BIOMERIEUX
K110745	HELICOBACTER PYLORI ELISA IGG TEST KIT	Mar 02, 2012	Substantially Equivalent	Gold Standard Diagnostics
K110899	GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT	Feb 01, 2012	Substantially Equivalent	Gold Standard Diagnostics
K052716	RAPIRUN H. PYLORI ANTIBODY DETECTION KIT	Nov 16, 2006	Substantially Equivalent	Otsuka Pharmaceutical Co., Ltd.
K052708	PYLO-PLUS	May 01, 2006	Substantially Equivalent	Arj Medical, Inc.
K053335	PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480	Mar 10, 2006	Substantially Equivalent	Meridian Bioscience, Inc.
K041238	HELICOBACTER PYLORI IGG ELISA	Dec 13, 2004	Substantially Equivalent	Biohit Plc
K032222	IMMUNOCARDSTAT HPSA	Dec 05, 2003	Substantially Equivalent	Meridian Bioscience, Inc.
K033067	PYLORI IGG	Nov 26, 2003	Substantially Equivalent	Trinity Biotech USA
K024360	INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST	Jun 10, 2003	Substantially Equivalent	Alfa Scientific Designs, Inc.
K024350	ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE	Apr 02, 2003	Substantially Equivalent	ACON Laboratories, Inc.
K024334	QUANTA LITE H.PYLORI IGA ELISA	Mar 27, 2003	Substantially Equivalent	Inova Diagnostics, Inc.
K022356	NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY	Oct 25, 2002	Substantially Equivalent	Nichols Institute Diagnostics
K014038	PYLORITEK VP TEST KIT 5140VP	Feb 08, 2002	Substantially Equivalent	Serim Research Corp.
K012588	OXOID PYLORI TEST KIT, MODEL DR0130M	Dec 10, 2001	Substantially Equivalent	Oxoid , Ltd.
K012411	HP-ONE	Sep 25, 2001	Substantially Equivalent	Gi Supply
K003794	ELISA TEST, SEROLOGY	Mar 30, 2001	Substantially Equivalent	Micro Detect, Inc.
K002023	MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714	Nov 13, 2000	Substantially Equivalent	Medmira Laboratories, Inc.
K001177	PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI	Nov 13, 2000	Substantially Equivalent	Enteric Products, Inc.
K001460	VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192	Oct 04, 2000	Substantially Equivalent	bioMerieux, Inc.
K002451	MODIFICATION TO: PRONTO DRY	Sep 29, 2000	Substantially Equivalent	Medical Instruments Corporation, AG
K000463	IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG	Jun 01, 2000	Substantially Equivalent	Diagnostic Products Corp.
K991697	UNI-GOLD H. PYLORI	Dec 21, 1999	Substantially Equivalent	Trinity Biotech, Plc
K990462	IS H. PYLORI IGG ELISA TEST SYSTEM	Sep 03, 1999	Substantially Equivalent	Columbia Bioscience, Inc.
K991820	HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI	Aug 12, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K991747	QUICKVUE ONE-STEP H. PYLORI II TEST	Aug 04, 1999	Substantially Equivalent	Quidel Corp.
K991248	PRONTO DRY	Jun 22, 1999	Substantially Equivalent	Medical Instruments Corporation Mic AG
K984544	THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S	Feb 18, 1999	Substantially Equivalent	Enteric Products, Inc.
K983255	MODIFICATION TO: PREMIER PLATINUM HPSA	Dec 17, 1998	Substantially Equivalent	Meridian Diagnostics, Inc.
K982362	ABBOTT TESTPACK PLUS H. PYLORI	Nov 18, 1998	Substantially Equivalent	Abbott Laboratories
K982790	QUANTA LITE H. PYLORI IGG ELISA	Nov 04, 1998	Substantially Equivalent	Inova Diagnostics, Inc.
K980798	BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST	Sep 22, 1998	Substantially Equivalent	Princeton BioMeditech Corp.
K980782	STAT-SIMPLE PYLORI	Aug 05, 1998	Substantially Equivalent	Saliva Diagnostic Systems, Inc.
K981396	PYLORIPROBE	Jul 30, 1998	Substantially Equivalent	Amdl, Inc.
K980821	HELICOBACTER PYLORI IGG ELISA TEST SYSTEM	Jul 30, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K980076	PREMIER PLATINUM HPSA	May 12, 1998	Substantially Equivalent	Meridian Diagnostics, Inc.
K972981	SHIELD HELICO-G2 ELISA KIT	Mar 17, 1998	Substantially Equivalent	Shield Diagnostics, Ltd.
K973508	PYLORI DETECT IGG	Mar 10, 1998	Substantially Equivalent	Micro Detect, Inc.
K973523	ACCUSTAT H. PYLORI ONE STEP TEST	Mar 03, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K972146	QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS	Jul 08, 1997	Substantially Equivalent	Consolidated Technologies, Inc.
K971537	PYLORISET EIA-G (68926)	Jun 27, 1997	Substantially Equivalent	Orion Diagnostica, Div. Orion Corp.
K964014	KENLOR H. PYLORI CONTROL SERUM	Mar 03, 1997	Substantially Equivalent	Kenlor Industries, Inc.
K965099	ACCUMETER H. PYLORI TEST	Feb 20, 1997	Substantially Equivalent	Chemtrak, Inc.
K964675	H.PYLORI CONTROLS	Jan 27, 1997	Substantially Equivalent	Pyramid Biological Corp.
K961508	IMMUNOCARD H. PYLORI	Jan 21, 1997	Substantially Equivalent	Meridian Diagnostics, Inc.
K952220	MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT	Sep 17, 1996	Substantially Equivalent	Meretek Diagnostics, Inc.
K953873	VARELISA HELICOBACTER PYLORI ANTIBODIES	Aug 30, 1996	Substantially Equivalent	Elias U.S.A., Inc.
K961221	PYLORI IGG ELISA TEST SYSTEM	Jul 30, 1996	Substantially Equivalent	Armkel, LLC
K960478	ACCUMETER H. PYLORI TEST	Jun 27, 1996	Substantially Equivalent	Chemtrak, Inc.
K960183	FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)	Jun 07, 1996	Substantially Equivalent	Smithkline Diagnostics, Inc.
K953686	HELISAL RAPID BLOOD TEST	May 21, 1996	Substantially Equivalent	Cortecs, Ltd.
K955085	HM-CAP EIA TEST (MODIFICATION)	Feb 09, 1996	Substantially Equivalent	Schiff & Co.
K952517	QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST	Feb 06, 1996	Substantially Equivalent	Quidel Corp.
K954926	HM-CAP CONTROL PANEL	Jan 30, 1996	Substantially Equivalent	E-Z-Em, Inc.
K953632	SERIM PYLORITEK TEST KIT	Dec 18, 1995	Substantially Equivalent	Serim Research Corp.
K944159	HM-CAP EIA KIT	Jul 18, 1995	Substantially Equivalent	Schiff & Co.
K943513	PS II	May 11, 1995	Substantially Equivalent	Washington Biotechnology
K944903	HP-FAST	Apr 20, 1995	Substantially Equivalent	Gi Supply
K942974	PYLORISET DRY	Apr 05, 1995	Substantially Equivalent	Orion Diagnostica, Div. Orion Corp.
K945558	PREMIER(TM) H. PYLORY	Mar 03, 1995	Substantially Equivalent	Meridian Diagnostics, Inc.
K941560	IMMUNOCARD H. PYLORI	Dec 08, 1994	Substantially Equivalent	Meridian Diagnostics, Inc.
K934863	FLEXSURE HP	May 18, 1994	Substantially Equivalent	Smithkline Diagnostics, Inc.
K924689	UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG	Aug 10, 1993	Substantially Equivalent	United Biotech, Inc.
K925190	PYLORISCREEN	Mar 23, 1993	Substantially Equivalent	New Horizons Diagnostics Co.
K923445	PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED	Sep 11, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K920827	AMRAD HEL-PTEST	Jul 14, 1992	Substantially Equivalent	Amrad
K915185	GAP IGG H.PYLORI MODIFIED	Mar 04, 1992	Substantially Equivalent	Biomerica, Inc.
K915851	QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)	Feb 21, 1992	Substantially Equivalent	Quidel Corp.
K904655	PYLORISET	Oct 21, 1991	Substantially Equivalent	Orion Diagnostica, Inc.
K912255	HYCOR PYLORAGEN HELICOBACTER PYLORI TEST	Oct 11, 1991	Substantially Equivalent	Hycor Biomedical, Inc.
K912215	PYLORITRAK	Oct 04, 1991	Substantially Equivalent	Bainbridge Laboratories, Inc.
K912442	QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST	Sep 16, 1991	Substantially Equivalent	Quidel Corp.
K900343	GAP-IGG	Aug 22, 1991	Substantially Equivalent	Biomerica, Inc.
K905409	EIA FOR DETECTION OF ANTIBODIES H. PYLORI	Jun 10, 1991	Substantially Equivalent	E-Z-Em, Inc.
K905468	PYLORI-G FIAX TEST KIT	May 07, 1991	Substantially Equivalent	Whittaker Bioproducts, Inc.
K905049	QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR	May 07, 1991	Substantially Equivalent	Quidel Corp.
K904738	PYLORI STAT TEST KIT	May 07, 1991	Substantially Equivalent	Whittaker Bioproducts, Inc.
K903099	QUIDEL HELICOBACTER PYLORI TEST	Apr 17, 1991	Substantially Equivalent	Quidel Corp.
K883641	SELECTIVE RAPID UREA	May 04, 1989	Substantially Equivalent	Remel Co.
K882199	CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST	Oct 06, 1988	Substantially Equivalent	Auspharm Intl. , Ltd.