510(k) · Cleared
ClearedBioplex 2200 Ebv Igg and Syphilis Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Mar 14, 2012 as substantially equivalent to K062211 (Bio-Rad Laboratories, Inc., 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 14, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951549 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK951549 Ebna Igg Eia Test SystemImmunoprobe, Inc. · 1996
- 1 generation backK062211 Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2006 · Recalled
- This deviceK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951549 | Ebna Igg Eia Test System | Immunoprobe, Inc. | 1996 | — |
| −1 | K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories, Inc. | 2006 | 2 |
| 0 (this device) | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System | 2006 |
| * | K063866 | Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemSummary page 4…iology Regulation Number 866.3830 Product Code LIP, JIX, JJY Legally Marketed Predicate Device BioPlex® 2200 Syphilis IgG Panel, k063 866 INTENDED USE / INDICATIONS FOR USE The BioPlex® 2200 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitati… | 2007 |
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 16 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
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. 2012, 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 BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of JgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen- I (EBV NA-i1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV 1gM kit as an aid in the laboratory diagnosis of infectious mononucleosis (TM). The EBV JgG kit is…
Read the full statement (247 words)
The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of JgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen- I (EBV NA-i1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV 1gM kit as an aid in the laboratory diagnosis of infectious mononucleosis (TM).
The EBV JgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
The BioPlex® 2200 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection Treponema pallidum 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 also confirms reactive test results form non-treponemal based screening assays.
The Syphilis IgO 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 as stated in the FDA summary.
https://510kreport.com/device/K120439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120439: Bioplex 2200 Ebv Igg and Syphilis Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120439
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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