510(k) · Cleared
Recalled · 2007HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrl Diagnostics · LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Cleared on Apr 14, 2000 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled once.
- Decided
- Apr 14, 2000
- Review
- 78 days
- Class
- Class II
- Product code
- LGC
- Recalls
- 1
- Predicates
- 0
17 later devices descend from it, 14 citing it directly.
- This deviceK000238 HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GMrl Diagnostics · 2000
- Descendant · cites it directly · 1 of its ownK121895 Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012
- Descendant · cites it directly · 1 of its ownK120625 Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics · 2012
- Descendant · cites it directly · 1 of its ownK090409 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 ownK243575 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2…Biokit, S.A. · 2025
- Descendant · cites it directly · 0 of its ownK213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1…Biokit, S.A. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K121895Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012 · cites it directly1descendant
- K120625Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics · 2012 · cites it directly1descendant
- K090409Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories · 2009 · cites it directly1descendant
- K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A. · 2025 · cites it directly0descendants
- K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G | Mrl Diagnostics | 2000 | — |
| +1 | K121895 | Elecsys HSV-2 Igg Immunoassay | Roche Diagnostics | 2012 | — |
| +1 | K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV | Roche Diagnostics | 2012 | — |
| +1 | K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection… | Bio-Rad Laboratories | 2009 | — |
| +1 | K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG… | Biokit, S.A. | 2025 | — |
| +1 | K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG… | Biokit, S.A. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGC? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 1714 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121895 | Elecsys HSV-2 Igg Immunoassay | 2012 | 1 |
| K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV | 2012 | 1 |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System | 2009 | 1 |
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | 2025 | 0 |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | 2023 | 0 |
| K181333 | ADVIA Centaur Herpes-1 IgG | 2018 | 0 |
| K181334 | ADVIA Centaur Herpes-2 IgG | 2018 | 0 |
| K162276 | SeraQuest Herpes Type 1 Specific IgG | 2016 | 0 |
| K143236 | Theranos Herpes Simplex Virus-1 IgG Assay | 2015 | 0 |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa Test | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2007 | Not classified | Z-1764-2008 | Process design | A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121895 (Roche Diagnostics, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LGC devicesLGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGC
FDA has decided no LGC device since 2007.
Median 510(k) review, days · LGC
Too few LGC 510(k)s in any year since 2007 to give a median.
Recalls per year · LGC
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGC
1in 2024
MAUDE reports naming product code LGC, 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 | 0 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 4 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000238
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026