# K971909: Virgo Ama Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jun 20, 1997 after 28 days
- Product code: DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Scimedx Mitochondrial Antibody Test System: named in the summary without a submission number

## Indications for use
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of antimitochondrial antibodies in human serum. The presence of mitochondrial antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of primary biliary cirrhosis(PBC)

Source page: https://510kreport.com/device/K971909
Methodology: https://510kreport.com/methodology