510(k) · Cleared
ClearedElecsys HSV-2 Igg Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 24, 2012 as substantially equivalent to K000238 (Mrl Diagnostics, 2000) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Aug 24, 2012
- Review
- 56 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K052133 (2005). 3 ancestors in all, the oldest K000238 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK052133 Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 2005
- 1 generation backK081338 Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol…Roche Diagnostics · 2008 · Recalled
- This deviceK121895 Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012
- Descendant · cites it directly · 0 of its ownK220924 Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022
Most influential descendants
Showing 1 of 1 · See all- K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052133 | Immunoscan RA Anti-CCP Test System | Eurodiagnostica | 2005 | — |
| −1 | K081338 | Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP | Roche Diagnostics | 2008 | 2 |
| 0 (this device) | K121895 | Elecsys HSV-2 Igg Immunoassay | Roche Diagnostics | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GSummary page 1…(assayed and unassayed) Product Code: MYF, JJX Predicate Device: Focus HerpeSelect 1 and 2 Immunoblot IgO (K000238) Continued on next page 510(k) Summary, Continued… | 2000 |
| * | K081338 | Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCPSummary page 14…ce: Charcteisti ElcsysPrei~onrolHSVEleesys PreciControl Anti-CCP (Candidate Device) (K081338) Intended Use The Eleesys PreciControl HSV is used Eleesys PreciControl Anti-CCP is for quality control of the… | 2008 |
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 |
|---|---|---|---|
| K220924 | Elecsys HSV-2 IgG (08948887160) | 2022 | 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K220924 (Roche Diagnostics, 2022) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K000238.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roche Elecsys HSV-2 IgG inmmoassay is a test for the in vitro qualitative determination of JgG 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 presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of…
Read the full statement (152 words)
The Roche Elecsys HSV-2 IgG inmmoassay is a test for the in vitro qualitative determination of JgG 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 presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of H-SV-2. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e inmmnoassay 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 and inmmocompromised patients or for use at point of care facilities.
The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
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/K121895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121895: Elecsys HSV-2 Igg Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121895
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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