510(k) · Cleared
ClearedBioplex 2200 HSV-1 and HSV-2 Igg Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Cleared on Jun 22, 2012 as substantially equivalent to K090409 (Bio-Rad Laboratories, 2009) after an 84-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jun 22, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- MXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000238 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK000238 HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 2000 · Recalled
- 1 generation backK090409 Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2009
- This deviceK120959 Bioplex 2200 HSV-1 and HSV-2 Igg KitBio-Rad Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G | Mrl Diagnostics | 2000 | 1 |
| −1 | K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection… | Bio-Rad Laboratories | 2009 | — |
| 0 (this device) | K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg Kit | Bio-Rad Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 MXJ? 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 MXJ device
- #1 K213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG…score 6.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemSummary page 2…ality control Material (JJY) (Assayed and Unassayed) Legally Marketed Predicate Device Biolex® 2200 HSV-1 & HSV-2 IgG Kit, k090409 INTENDED USE /INDICA TIONS FOR USE Biolex® 2200 HSV-1 & HSV-2 IgG Kit The Biolex® 2200 HSV-1 & l-SV-2 IgO kit is a multiplex f… | 2009 |
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 12 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All MXJ devicesMXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MXJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MXJ
123in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXJ
No recall names MXJ since 2007.
Adverse event reports per year · MXJ
1in 2025
MAUDE reports naming product code MXJ, 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 | 3 | 123 | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 140 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Biolex® 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1I or 1-SV-2 infection. The predictive value of positive or…
Read the full statement (235 words)
The Biolex® 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1I or 1-SV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of IISV-lI and HSV-2.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
The Biolex® 2200 US V-i & HSV-2 IgG kit is intended for use with the Bid-Rad Biolex®'2200 System.
The Biolex® 2200 IISV-1 & HSV-2 IgG Calibrator Set is intended for the calibration of the Bioex® 2200 HSV-1 & HSV-2 IgG Reagent Pack.
The Biollex® 2200 HS-1 VI & HSV-2 IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the Biolex®'2200 Instrument and Biolex® 2200 HSV-1 & HSV-2 IgG Reagent Pack in the clinical laboratory. The performance of the Biolex® 2200 HSV-I & HSV-2 IgO Control Set has not been established with any other HSV-1I and HSV-2 antibody assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120959: Bioplex 2200 HSV-1 and HSV-2 Igg Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120959
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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