510(k) · Cleared
Recalled · 2010Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Mar 19, 2007 as substantially equivalent to K971502 (Scimedx Tekfile Services, 1997) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Mar 19, 2007
- Review
- 80 days
- Class
- Class II
- Product code
- LIP
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971502 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK971502 Serodia TP-PAScimedx Tekfile Services · 1997
- This deviceK063866 Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2007
- Descendant · cites it directly · 0 of its ownK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120439Bioplex 2200 Ebv Igg and Syphilis 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 | K971502 | Serodia TP-PA | Scimedx Tekfile Services | 1997 | — |
| 0 (this device) | K063866 | Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories | 2007 | — |
| +1 | K120439 | Bioplex 2200 Ebv Igg and Syphilis Igg | Bio-Rad Laboratories, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIP device
- #1 K241534 VITROS Immunodiagnostic Products Syphilis…score 9.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K971502 | Serodia TP-PASummary page 2…51()Date IMacro-Vue RPR Card (Becton Dickenson) Pre-Amendment IN/A Serodia TPPA (Fujirebie Inc.) 971502 11/13/1997 Trep-Chek Anti-Treponemal EIA (Phoenix Bio-Tech Corp.) 001552 1011912000 DEVICE… | 1997 |
| * | K001552 | Trepchek Treponemal Antibody EiaSummary page 2…IN/A Serodia TPPA (Fujirebie Inc.) 971502 11/13/1997 Trep-Chek Anti-Treponemal EIA (Phoenix Bio-Tech Corp.) 001552 1011912000 DEVICE DESCRIPTION The Syphilis IgG kit uses multiplex flow immunoassay, a methodology that greatly res… | 2000 |
| * | — | Macro-Vue RPR Card (Becton Dickenson) Named without a submission number |
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 |
|---|---|---|---|
| K120439 | Bioplex 2200 Ebv Igg and Syphilis Igg | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2010 | Not classified | Z-1650-2011 | Other | An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges. |
| Nov 13, 2007 | Not classified | Z-1156-2008 | Nonconforming Material/Component | False negative results due to reagent packs exhibiting low signal. |
| Sep 25, 2007 | Not classified | Z-0256-2008 | Labeling Change Control | Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K120439 (Bio-Rad Laboratories, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LIP devicesLIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LIP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIP
170in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIP
112in 2025
MAUDE reports naming product code LIP, 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 | 1 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 3 | 170 | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 46 |
| 2021 | 1 | — | 2 | 54 |
| 2022 | 0 | — | 2 | 44 |
| 2023 | 0 | — | 0 | 66 |
| 2024 | 2 | — | 0 | 73 |
| 2025 | 0 | — | 0 | 112 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Bio-Rad Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system is also indicated for use in confirming reactive test results from non-treponemal based screening assays. The Syphilis IgG kit is intended for use with…
Read the full statement (131 words)
The Bio-Rad Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system is also indicated for use in confirming reactive test results from non-treponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors.
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
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/K063866 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063866: Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063866
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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