# K033528: Mesacup-2 Test JO-1, Model 10756

- Pathway: 510(k) (Traditional)
- Applicant: Rhigene, Inc.
- Decided: Dec 22, 2003 after 45 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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 K926562 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926562: Quanta Lite (TM) JO-1 Elisa Kit, Inova Diagnostics, Inc. (1993) Summary page 1.

## Indications for use
The MESACUP-2 TEST Jo-l is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Jo-i antibodies in human serum as an aid in the diagnosis of polymyositis and/or dermatomyositis, or other related connective tissue diseases. The MESACUP-2 TEST Jo-1 is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K033528
Methodology: https://510kreport.com/methodology