Product Code: MOI FDA class 2 21 CFR 866.6010

System, Test, Immunological, Antigen, Tumor

Immunology

The Tumor Antigen Immunological Test System is an in vitro diagnostic device used to detect and measure tumor-associated antigens in patient samples, supporting the diagnosis and monitoring of certain cancers. Classified as FDA Class 2 under 21 CFR 866.6010 in the Immunology specialty, it requires 510(k) premarket notification. The product code is MOI, and it is eligible for third-party 510(k) review.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: MOI
Device Class: FDA class 2
Regulation Number: 866.6010
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240403	Access BR Monitor	May 09, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K233946	IMMULITE® 2000 BR-MA	Mar 13, 2024	Substantially Equivalent	Siemens Healthcare Diagnostics Products, Ltd.
K192524	Lumipulse G CA15-3	Sep 04, 2020	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K193489	ADVIA Centaur BR	Feb 13, 2020	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K192777	ADVIA Centaur CA 15-3 assay	Nov 22, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K181492	Elecsys CA 15-3 II	Jun 22, 2018	Substantially Equivalent	Roche Diagnostics
K171605	Elecsys CA 15-3 II	Feb 20, 2018	Substantially Equivalent	Roche Diagnostics
K100344	DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605	Apr 18, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K072612	ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647	Oct 26, 2007	Substantially Equivalent	Beckman Coulter, Inc.
K042732	ARCHITECT CA 15-3 ASSAY	Dec 22, 2004	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K033036	BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647	Feb 03, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K022178	CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Nov 12, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K013984	IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR	Mar 28, 2002	Substantially Equivalent	Diagnostic Products Corp.
K012357	CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM	Feb 28, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K010796	AIA-PACK BRCA, ST AIA PACK BRCA	Aug 16, 2001	Substantially Equivalent	Tosoh Medics, Inc.
K010588	ELECSYSCA 15-3 II ASSAY	Mar 28, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K001468	ELECSYS CA 15-3 TEST SYSTEM	Oct 23, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K983690	VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK	Feb 02, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K982680	CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY	Oct 15, 1998	Substantially Equivalent	Chiron Diagnostics Corp.
K981698	ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)	Jul 10, 1998	Substantially Equivalent	Chiron Corp.
K980190	ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)	Mar 06, 1998	Substantially Equivalent	Chiron Corp.
K964703	THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	Dec 01, 1997	Substantially Equivalent	Bayer Corp.
K964407	IMX CA 15-3	Nov 10, 1997	Substantially Equivalent	Abbott Laboratories
K965141	TRUQUANT BR RIA	Oct 31, 1997	Substantially Equivalent	Biomira USA, Inc.
K963926	AXSYM CA 15-3	Sep 15, 1997	Substantially Equivalent	Abbott Laboratories
K970695	ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)	Aug 08, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K971418	CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER	Jul 17, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K963803	CENTOCOR CA 15-3 RIA MODEL NO. 800-033	May 23, 1997	Substantially Equivalent	Centocor, Inc.