# K981209: Monkey Oesophagus Ifa Diagnostic Test Kits

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Oct 22, 1998 after 203 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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 kit is intended for screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies as an aid in the diagnosis of celiac disease.

Source page: https://510kreport.com/device/K981209
Methodology: https://510kreport.com/methodology