# K030238: Bindazyme Anti-Mitochondria M2 Iggam Eia Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Mar 24, 2003 after 60 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.

Source page: https://510kreport.com/device/K030238
Methodology: https://510kreport.com/methodology