Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5090](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5090) → DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control # DBM · Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control _Immunology · 21 CFR 866.5090 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM ## Overview - **Product Code:** DBM - **Device Name:** Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control - **Regulation:** [21 CFR 866.5090](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5090) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K181556](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K181556.md) | EliA M2 Immunoassay | Phadia AB | Jul 13, 2018 | SESE | | [K163525](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K163525.md) | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Inova Diagnostics, Inc. | Sep 5, 2017 | SESE | | [K163133](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K163133.md) | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | Aug 8, 2017 | SESE | | [K141375](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K141375.md) | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Phadia US, Inc. | Feb 13, 2015 | SESE | | [K092736](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K092736.md) | EUROIMMUN ANTI-M2-3E ELISA (IGG) | Euroimmun Us, Inc. | Sep 2, 2010 | SESE | | [K052262](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K052262.md) | QUANTA LITE M2 EP (MIT3) ELISA | Inova Diagnostics, Inc. | Oct 27, 2005 | SESE | | [K031308](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K031308.md) | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | Rhigene, Inc. | Sep 26, 2003 | SESE | | [K030238](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K030238.md) | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | The Binding Site, Ltd. | Mar 24, 2003 | SESE | | [K982121](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K982121.md) | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Trace Scientific , Ltd. | Sep 17, 1998 | SESE | | [K971909](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K971909.md) | VIRGO AMA ELISA KIT | Hemagen Diagnostics, Inc. | Jun 20, 1997 | SESE | | [K962452](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K962452.md) | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | Hycor Biomedical, Inc. | Nov 25, 1996 | SESE | | [K945607](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K945607.md) | VARELISA M2 ANTIBODIES | Elias U.S.A., Inc. | Jan 24, 1995 | SESE | | [K940251](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K940251.md) | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | May 3, 1994 | SESE | | [K930143](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K930143.md) | AYNELISA M2-ANTIBODIES | Elias U.S.A., Inc. | May 11, 1993 | SESE | | [K921183](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K921183.md) | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | Jun 19, 1992 | SESE | | [K843181](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K843181.md) | AUTOFLUOR IV SYSTEM | Tech America Diagnostics | Sep 17, 1984 | SESE | | [K842247](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K842247.md) | MELOY AUTOANTIBODY TEST SYS | Meloy Laboratories, Inc. | Jun 26, 1984 | SESE | | [K831358](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K831358.md) | AUTOANTIBODY SCREEN TEST SYSTEM | Zeus Scientific, Inc. | Jun 15, 1983 | SESE | | [K831100](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K831100.md) | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | Medical Diagnostics, Ca. | May 4, 1983 | SESE | | [K810984](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM/K810984.md) | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | Immuno-Products Industries | May 1, 1981 | SESE | ## Top Applicants - Elias U.S.A., Inc. — 2 clearances - Inova Diagnostics, Inc. — 2 clearances - Zeus Scientific, Inc. — 2 clearances - Bioware Products — 1 clearance - Calbiochem — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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