510(k) · Cleared
ClearedBioplex 2200 HSV-1 and HSV-2 Igg 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 · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Cleared on May 8, 2009 as substantially equivalent to K021429 (Focus Technologies, Inc., 2002) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- May 8, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- MXJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000238 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000238 HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 2000 · Recalled
- This deviceK090409 Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2009
- Descendant · cites it directly · 0 of its ownK120959 Bioplex 2200 HSV-1 and HSV-2 Igg KitBio-Rad Laboratories · 2012
Most influential descendants
Showing 1 of 1 · See all- K120959Bioplex 2200 HSV-1 and HSV-2 Igg KitBio-Rad Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G | Mrl Diagnostics | 2000 | 1 |
| 0 (this device) | K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection… | Bio-Rad Laboratories | 2009 | — |
| +1 | 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 |
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 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 6.1 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K021429 | Herpeselect 1 Elisa Igg, Model EL0910GSummary page 2…EDICATE DEVICE Date Focus HerpesSelect 1 ELISA IgG k021429 7/29/2002 Focus HerpesSelect 2 ELISA IgG k021486 8/1/200… | 2002 |
| * | K021486 | Herpeselect 2 Elisa Igg, Model ELO920GSummary page 2…erpesSelect 1 ELISA IgG k021429 7/29/2002 Focus HerpesSelect 2 ELISA IgG k021486 8/1/2002 Focus HerpesSelect 1 and 2 Immunoblot IgG k000238 4/14/200… | 2002 |
| * | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GSummary page 2…HerpesSelect 2 ELISA IgG k021486 8/1/2002 Focus HerpesSelect 1 and 2 Immunoblot IgG k000238 4/14/2000 DEVICE DESCRIPTION The BioPlex 2200 HSV-1 & HSV-2 IgG kit uses multiplex flow immunoassay, a methodolo… | 2000 |
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 |
|---|---|---|---|
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg Kit | 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K120959 (Bio-Rad Laboratories, 2012) has gone furthest, with 0 descendants of its own.
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. 2009, 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 BioPlexTM 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-I or HSV-2 infection. The predictive value of positive or…
Read the full statement (147 words)
The BioPlexTM 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-I or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV- 1 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 BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
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/K090409 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090409: Bioplex 2200 HSV-1 and HSV-2 Igg 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 3, 2026. https://510kreport.com/device/K090409
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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