510(k) · Cleared
ClearedBioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · PUQ Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
Cleared on May 19, 2017 as substantially equivalent to K092587 (Bio-Rad Laboratories, 2010) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- May 19, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- PUQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933549 (1994). 4 ancestors in all, the oldest K923166 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK933549 Vidas CMV Igm AssayBiomerieux Vitek, Inc. · 1994 · Recalled
- 1 generation backK092587 Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte…Bio-Rad Laboratories · 2010
- This deviceK170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex…Bio-Rad Laboratories · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933549 | Vidas CMV Igm Assay | Biomerieux Vitek, Inc. | 1994 | 2 |
| −1 | K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection… | Bio-Rad Laboratories | 2010 | — |
| 0 (this device) | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC… | Bio-Rad Laboratories | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2001 | 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 PUQ? 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? (2)
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 |
|---|---|---|---|
| * | K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemSummary page 6…300 (0.03%) and sodium azide (<0.1%) as preservatives. Substantial Equivalence Information: 1. Predicate device name(s): BioPlex 2200 Rubella and CMV IgM Kit, K092587 bioMeriéux, Inc. VIDAS® TOXO IgM, K923166 2. Comparison with predicate: Toxoplasma gondii IgM Predicate Device: V… | 2010 |
| * | K923166 | Vidas Toxoplasma Gondii Igm AsssaySummary page 6…atives. Substantial Equivalence Information: 1. Predicate device name(s): BioPlex 2200 Rubella and CMV IgM Kit, K092587 bioMeriéux, Inc. VIDAS® TOXO IgM, K923166 2. Comparison with predicate: Toxoplasma gondii IgM Predicate Device: VIDAS® TOXO IgM… | 1993 |
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.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 16.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All PUQ devicesPUQ Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PUQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PUQ
Too few PUQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PUQ
No recall names PUQ since 2007.
Adverse event reports per year · PUQ
No MAUDE report names PUQ since 2007.
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 | 0 |
| 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 | 1 | — | 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?
BioPlex 2200 ToRC IgM Kit The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin). The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent T. gondii…
Read the full statement (224 words)
BioPlex 2200 ToRC IgM Kit
The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin).
The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the ToRC IgM assay 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 point of care facilities.
BioPlex 2200 ToRC IgM Calibrator Set
The BioPlex 2200 ToRC IgM Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgM Reagent Pack.
BioPlex 2200 ToRC IgM Control Set
The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.
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/K170509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170509: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM 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/K170509
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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