510(k) · Cleared
ClearedCopalis One Immunoassay System/Toxoplasma Gondii/Rubella/CMV Total Antibody Assays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sienna Biotech, Inc. · LQN Latex Agglutination Assay, Rubella
Cleared on Oct 31, 1996 after a 182-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 31, 1996
- Review
- 182 days
- Class
- Class II
- Product code
- LQN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BioWhittaker Toxostat Named without a submission number | |
| * | — | Becton Dickinson And Co. Rubascan Named without a submission number | |
| * | — | Becton Dickinson And Co. CMVscan Named without a submission number | |
| * | — | Abbott IMx Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LQN devicesLQN Latex Agglutination Assay, Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQN
FDA has decided no LQN device since 2007.
Median 510(k) review, days · LQN
Too few LQN 510(k)s in any year since 2007 to give a median.
Recalls per year · LQN
No recall names LQN since 2007.
Adverse event reports per year · LQN
1in 2009
MAUDE reports naming product code LQN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ | Inmunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The…
Read the full statement (204 words)
The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ | Inmunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of these assays 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 these assays are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results).
These assays has not been FDA cleared or approved for the screening of blood or plasma donors.
The assay will also be offered as separate microparticle immunoassays 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 intended use of the individual assays will be specific to the individual antibodies detected but, other than that, will remain the same as the combination assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961784 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961784: Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/CMV Total Antibody Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961784
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026