# K982027: Modification to Copalis CMV Total Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Nov 25, 1998 after 176 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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) Copalis® CMV Total Antibody Assay: named in the summary without a submission number
- (no number) Abbott CMV Total AB EIA: named in the summary without a submission number
- (no number) Becton Dickinson CMVscan: named in the summary without a submission number

## Indications for use
The Copalis™ TORC Total Antibody Assay is used for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus in men and women of child-bearing age. The Copalis™ CMV Total Antibody Assay is used for the qualitative detection of total antibodies (1gG and IgM) to cytomegalovirus in men and women of child-bearing age. The presence of antibodies in these populations is indicative of recent or prior infection. These assays are not intended for screening of blood or plasma donors. The Copalis TORC Total Antibody Assay and the Copalis™ CMV Total Antibody Assay can be used in both the clinical and physician office laboratories. These assays can also be used to determine the CMV immune status of transplant donors and recipients.

Source page: https://510kreport.com/device/K982027
Methodology: https://510kreport.com/methodology