# K040200: Mesacup-2 Test Cenp-B

- Pathway: 510(k) (Traditional)
- Applicant: Rhigene, Inc.
- Decided: Mar 4, 2004 after 35 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K060431: Anti Rna Polymerase Iii Elisa Kit, Model 7805 (2006), 0 descendants of its own

## Indications for use
The MESACUP-2 Test CENP-B is a semi-quantitative enzymc-linkcd immunosorbcnt assay (ELISA) for the detection of anti-CENP-B antibodies in human serum. The MESACUP-2 Test CENP-B is intended for in vitro diagnostic use as an aid ill the diagnosis of CREST syndrome and related connective tissue diseases. The MESACUP-2 Test CENP-B is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K040200
Methodology: https://510kreport.com/methodology