# K031308: Rhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760

- Pathway: 510(k) (Traditional)
- Applicant: Rhigene, Inc.
- Decided: Sep 26, 2003 after 155 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
Longest line of descent: 1 generation back to K933180 (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)
- K933180: Quanta Lite Mitochondria M2 Elisa, Inova Diagnostics, Inc. (1993). Our reading of the summary gave K933150, FDA’s number for Noblepharma Dec 500 Straight Handpiece (Nobelpharma USA, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Quanta Lite Mitochondria M2 ELISA”.

## Indications for use
The MESACUP-2 TEST Mitochondria M2 is semiquantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Mitochondrial antibodies in human serum as an aid in the diagnosis of primary biliary cirrhosis. The MESACUP-2 TEST Mitochondria M2 is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K031308
Methodology: https://510kreport.com/methodology