# K993291: Copalis Rubella Igm

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Feb 10, 2000 after 132 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories IMx Rubella IgM (MEIA): named in the summary without a submission number

## Indications for use
The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection.

Source page: https://510kreport.com/device/K993291
Methodology: https://510kreport.com/methodology