510(k) · Cleared
Recalled · Class II · 2021ADVIA Centaur Herpes-2 IgG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Cleared on Aug 23, 2018 as substantially equivalent to K000238 (Mrl Diagnostics, 2000) after a 94-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Aug 23, 2018
- Review
- 94 days
- Class
- Class II
- Product code
- MYF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000238 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000238 HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 2000 · Recalled
- This deviceK181334 ADVIA Centaur Herpes-2 IgGBiokit, S.A. · 2018
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) | K181334 | ADVIA Centaur Herpes-2 IgG | Biokit, S.A. | 2018 | — |
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 MYF? 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 MYF device
- #1 K243575 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG…score 8.8 · 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 |
|---|---|---|---|
| * | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GSummary page 4…Product Code MYF Classification Panel Microbiology 6. Predicate Device K000238 (Focus HerpeSelect 1 and 2 Immunoblot IgG) 007_510(k) Summary Traditional 510(k): ADVIA Centaur Herpes-2 IgG P… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2021 | Class II | Z-1274-2021 | Under Investigation by firm | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 13 other devices also cite its predicate K000238.
How does its category compare?
All MYF devicesMYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MYF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYF
Too few MYF 510(k)s in any year since 2007 to give a median.
Recalls per year · MYF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MYF
43in 2025
MAUDE reports naming product code MYF, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 252 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA Centaur® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the…
Read the full statement (126 words)
The ADVIA Centaur® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum and plasma (EDTA and lithium heparin).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181334: ADVIA Centaur Herpes-2 IgG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181334
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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