COPALIS TORC TOTAL ANTIBODY ASSAY
Device Facts
| Record ID | K970931 |
|---|---|
| Device Name | COPALIS TORC TOTAL ANTIBODY ASSAY |
| Applicant | Sienna Biotech, Inc. |
| Product Code | LQN · Microbiology |
| Decision Date | Apr 24, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3510 |
| Device Class | Class 2 |
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.
Device Story
Copalis TORC Total Antibody Assay utilizes Coupled Particle Light Scattering (Copalis) technology for immunoassay. Input: human serum sample. Principle: antibody-dependent particle aggregation; latex microparticles coated with inactivated T. gondii, rubella, and CMV antigens aggregate when specific antibodies are present. System agitates sample for 10 minutes; detector measures changes in light scattering by discriminating particle sizes and counting reacted vs. unreacted particles. Output: qualitative antibody detection based on aggregation levels relative to cutoff. Used in physician office laboratories (POLs) or clinical settings; operated by laboratory personnel. Results assist clinicians in determining patient immune status or immunological experience and identifying recent infection via seroconversion.
Clinical Evidence
Clinical testing compared Copalis TORC to Abbott IMx assays using 250 serum samples. T. gondii: 91.4% sensitivity, 98.6% specificity. Rubella: 98.7% sensitivity, 100% specificity. CMV: 94.4% sensitivity, 100% specificity. POL proficiency study (3 sites, 4 operators) showed 100% agreement with expected results. Reproducibility assessed via 14-member blinded panel and duplicate testing; total %CV ranged from 2.3% to 15.8% across analytes.
Technological Characteristics
Uses Coupled Particle Light Scattering (Copalis) technology. Employs latex microparticles coated with inactivated T. gondii, rubella, and CMV antigens. Detection system measures light scattering changes via particle size discrimination and counting. System is designed for use with the Copalis One Immunoassay System.
Indications for Use
Indicated for qualitative detection of total IgG and IgM antibodies to Toxoplasma gondii, rubella, and CMV in human serum to determine immune status or immunological experience. Used to demonstrate seroconversion in paired sera. Not for blood/plasma donor screening.
Regulatory Classification
Identification
Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.
Predicate Devices
- Abbott IMx Toxo IgG 2.0
- Abbott IMx Rubella IgG 2.0
- Abbott IMx CMV IgG
