DBM · Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology · 21 CFR 866.5090 · Class 2
Overview
| Product Code | DBM |
|---|---|
| Device Name | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Regulation | 21 CFR 866.5090 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 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 | EliA M2 Immunoassay | Phadia AB | Jul 13, 2018 | SESE |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Inova Diagnostics, Inc. | Sep 5, 2017 | SESE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | Aug 8, 2017 | SESE |
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Phadia US, Inc. | Feb 13, 2015 | SESE |
| K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) | Euroimmun Us, Inc. | Sep 2, 2010 | SESE |
| K052262 | QUANTA LITE M2 EP (MIT3) ELISA | Inova Diagnostics, Inc. | Oct 27, 2005 | SESE |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | Rhigene, Inc. | Sep 26, 2003 | SESE |
| K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | The Binding Site, Ltd. | Mar 24, 2003 | SESE |
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Trace Scientific , Ltd. | Sep 17, 1998 | SESE |
| K971909 | VIRGO AMA ELISA KIT | Hemagen Diagnostics, Inc. | Jun 20, 1997 | SESE |
| K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | Hycor Biomedical, Inc. | Nov 25, 1996 | SESE |
| K945607 | VARELISA M2 ANTIBODIES | Elias U.S.A., Inc. | Jan 24, 1995 | SESE |
| K940251 | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | May 3, 1994 | SESE |
| K930143 | AYNELISA M2-ANTIBODIES | Elias U.S.A., Inc. | May 11, 1993 | SESE |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | Jun 19, 1992 | SESE |
| K843181 | AUTOFLUOR IV SYSTEM | Tech America Diagnostics | Sep 17, 1984 | SESE |
| K842247 | MELOY AUTOANTIBODY TEST SYS | Meloy Laboratories, Inc. | Jun 26, 1984 | SESE |
| K831358 | AUTOANTIBODY SCREEN TEST SYSTEM | Zeus Scientific, Inc. | Jun 15, 1983 | SESE |
| K831100 | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | Medical Diagnostics, Ca. | May 4, 1983 | SESE |
| K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | Immuno-Products Industries | May 1, 1981 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 2 clearances
- Inova Diagnostics, Inc. — 2 clearances
- Elias U.S.A., Inc. — 2 clearances
- Trace Scientific , Ltd. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
