# K970931: Copalis Torc Total Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sienna Biotech, Inc.
- Decided: Apr 24, 1997 after 48 days
- Product code: LQN (Latex Agglutination 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 IMx Toxo IgG 2.0: named in the summary without a submission number
- (no number) Abbott IMx Rubella IgG 2.0: named in the summary without a submission number
- (no number) Abbott IMx CMV IgG: named in the summary without a submission number

## Indications for use
The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to determine the patient’s immune status for rubella and to determine the patient’s immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Source page: https://510kreport.com/device/K970931
Methodology: https://510kreport.com/methodology