510(k) · Cleared
ClearedElecsys HSV-2 IgG (08948887160)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Cleared on Oct 12, 2022 as substantially equivalent to K121895 (Roche Diagnostics, 2012) after a 195-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Oct 12, 2022
- Review
- 195 days
- Class
- Class II
- Product code
- MYF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052133 (2005). 4 ancestors in all, the oldest K000238 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK052133 Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 2005
- 2 generations backK081338 Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol…Roche Diagnostics · 2008 · Recalled
- 1 generation backK121895 Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012
- This deviceK220924 Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052133 | Immunoscan RA Anti-CCP Test System | Eurodiagnostica | 2005 | — |
| −2 | K081338 | Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP | Roche Diagnostics | 2008 | 2 |
| −1 | K121895 | Elecsys HSV-2 Igg Immunoassay | Roche Diagnostics | 2012 | — |
| 0 (this device) | K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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
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 |
|---|---|---|---|
| * | K121895 | Elecsys HSV-2 Igg ImmunoassaySummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K121895 Elecsys HSV-2 IgG MYF IDevice Description… | 2012 |
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 17 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2022, 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?
Immunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value…
Read the full statement (132 words)
Immunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
This 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, or immunocompromised patients or for use at point-of-care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220924 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220924: Elecsys HSV-2 IgG (08948887160).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220924
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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