510(k) · Cleared
ClearedBioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · OMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Cleared on Feb 23, 2009 as substantially equivalent to K993319 (bioMerieux, Inc., 2000) and 2 other predicates after a 418-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Feb 23, 2009
- Review
- 418 days
- Class
- Class II
- Product code
- OMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902925 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK902925 Vitek Immunodiagnostic Assay System (Vidas) (RBG)Vitek Systems, Inc. · 1990
- This deviceK080008 Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK120572 Bioplex 2200 Torc IggBio-Rad Laboratories, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120572Bioplex 2200 Torc IggBio-Rad Laboratories, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902925 | Vitek Immunodiagnostic Assay System (Vidas) (RBG) | Vitek Systems, Inc. | 1990 | — |
| 0 (this device) | K080008 | Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set | Bio-Rad Laboratories, Inc. | 2009 | — |
| +1 | K120572 | Bioplex 2200 Torc Igg | Bio-Rad Laboratories, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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 OMI? 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? (3)
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 |
|---|---|---|---|
| * | K993319 | Vidas Toxo Igg II (TXG) Assay Model 30 210Summary page 1…Multi-analyte controls, all kinds (assayed and unassayed) 3. PREDICATE DEVICES · bioMeri~ux VIDAS®TOXO lgG II K993319 * bioMeri6ux VIDAS® Rubella IgG K902925 * bioMeri6ux VIDAS® CMV IgG… | 2000 |
| * | K902925 | Vitek Immunodiagnostic Assay System (Vidas) (RBG)Summary page 1…ed and unassayed) 3. PREDICATE DEVICES · bioMeri~ux VIDAS®TOXO lgG II K993319 * bioMeri6ux VIDAS® Rubella IgG K902925 * bioMeri6ux VIDAS® CMV IgG K920661 . ' .'"'… | 1990 |
| * | K920661 | Vidas CMV Igg AssaySummary page 1…gG II K993319 * bioMeri6ux VIDAS® Rubella IgG K902925 * bioMeri6ux VIDAS® CMV IgG K920661 . ' .'"' Bio-Rad Laboratories, Inc. 510(k) February 18, 2009… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120572 | Bioplex 2200 Torc Igg | 2012 | 0 |
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.
What does this lineage say?
How does its category compare?
All OMI devicesOMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMI
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OMI
Too few OMI 510(k)s in any year since 2007 to give a median.
Recalls per year · OMI
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMI
6in 2012
MAUDE reports naming product code OMI, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 1 | 4 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 6 |
| 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 BioPlex 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondi) and Rubella, and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma. The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status to T. gondii, Rubella…
Read the full statement (224 words)
The BioPlex 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondi) and Rubella, and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma.
The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.
The BioPlex 2200 ToRC IgG Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgG Reagent Pack.
The BioPlex 2200 ToRC IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex ToRG IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 ToRC IgG Control Set has not been established with any other Toxoplasma gondii, Rubella or Cytomegalovirus (CMV) IgG antibody assays.
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/K080008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080008: Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026