# K071961: Mesacup Models BP180 and BP230 Elisa Kits

- Pathway: 510(k) (Traditional)
- Applicant: Mbl International Corporation
- Decided: Aug 25, 2008 after 406 days
- Product code: OEG (Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230)
- 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
Longest line of descent: 1 generation back to K891098 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902237: Medica Iif Anti-Skin Antibody Test Kit, Medica Corp. (1990) Summary page 1.
- K891098: Anti-Skin Antibody Test (Monkey Esophagus Sections), Immco Diagnostics, Inc. (1989) Summary page 1.
- K891099: Anti-Skin Antibody Test (Monkey/Guin Pig Esoph Sec), Immco Diagnostics, Inc. (1989) Summary page 1.

## Indications for use
The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BPI80 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies..

Source page: https://510kreport.com/device/K071961
Methodology: https://510kreport.com/methodology