Product Code: DBM FDA class 2 21 CFR 866.5090

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Immunology

This is an immunological reagent kit for detecting antimitochondrial antibodies (AMA) using indirect immunofluorescence, providing antigen substrate and control components for diagnosing primary biliary cholangitis, in which AMA are present in approximately 95% of patients. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DBM, regulated under 21 CFR 866.5090, within the Immunology specialty.

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FEI Numbers

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Basic Information

Product Code: DBM
Device Class: FDA class 2
Regulation Number: 866.5090
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 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K181556	EliA M2 Immunoassay	Jul 13, 2018	Substantially Equivalent	Phadia AB
K163525	QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls	Sep 05, 2017	Substantially Equivalent	Inova Diagnostics, Inc.
K163133	ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA	Aug 08, 2017	Substantially Equivalent	Immco Diagnostics, Inc.
K141375	ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250	Feb 13, 2015	Substantially Equivalent	Phadia US, Inc.
K092736	EUROIMMUN ANTI-M2-3E ELISA (IGG)	Sep 02, 2010	Substantially Equivalent	Euroimmun Us, Inc.
K052262	QUANTA LITE M2 EP (MIT3) ELISA	Oct 27, 2005	Substantially Equivalent	Inova Diagnostics, Inc.
K031308	RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760	Sep 26, 2003	Substantially Equivalent	Rhigene, Inc.
K030238	BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT	Mar 24, 2003	Substantially Equivalent	The Binding Site, Ltd.
K982121	ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT	Sep 17, 1998	Substantially Equivalent	Trace Scientific , Ltd.
K971909	VIRGO AMA ELISA KIT	Jun 20, 1997	Substantially Equivalent	Hemagen Diagnostics, Inc.
K962452	HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA	Nov 25, 1996	Substantially Equivalent	Hycor Biomedical, Inc.
K945607	VARELISA M2 ANTIBODIES	Jan 24, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K940251	MITOCHONDRIA EIA TEST KIT	May 03, 1994	Substantially Equivalent	David A. Fuccillo, Ph.D.
K930143	AYNELISA M2-ANTIBODIES	May 11, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K921183	DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT	Jun 19, 1992	Substantially Equivalent	Shield Diagnostics, Ltd.
K843181	AUTOFLUOR IV SYSTEM	Sep 17, 1984	Substantially Equivalent	Tech America Diagnostics
K842247	MELOY AUTOANTIBODY TEST SYS	Jun 26, 1984	Substantially Equivalent	Meloy Laboratories, Inc.
K831358	AUTOANTIBODY SCREEN TEST SYSTEM	Jun 15, 1983	Substantially Equivalent	Zeus Scientific, Inc.
K831100	MEDICA IIF-MULTIPLE ANTIBODY TEST KIT	May 04, 1983	Substantially Equivalent	Medical Diagnostics, Ca.
K810984	ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST	May 01, 1981	Substantially Equivalent	Immuno-Products Industries
K810863	KALLESTAD HEP-2 CELL LINE SUBSTRATE	Apr 14, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K802308	T/K (ATA/AMA) UNIVERSAL BIOPAK	Dec 01, 1980	Substantially Equivalent	Bioware Products
K800821	AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY	Apr 24, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K800229	IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT	Feb 21, 1980	Substantially Equivalent	Clinical Sciences, Inc.
K790295	TEST KIT, IIF-AMA	May 25, 1979	Substantially Equivalent	Medica Corp.
K771993	AFT SYSTEM	Nov 02, 1977	Substantially Equivalent	Calbiochem
K760155	TEST, (IVDP) MITOCHONDRIAL ANTIBODY	Jul 20, 1976	Substantially Equivalent	Zeus Scientific, Inc.