510(k) · Cleared
ClearedCmvgen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · LJO Antigen, Iha, Cytomegalovirus
Cleared on May 1, 1998 as substantially equivalent to K841520 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1984) after a 157-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- May 1, 1998
- Review
- 157 days
- Class
- Class II
- Product code
- LJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K841520 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK841520 CMV Latex Agglutination Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1984
- This deviceK974456 CmvgenInstrumentation Laboratory CO · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841520 | CMV Latex Agglutination Test Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984 | — |
| 0 (this device) | K974456 | Cmvgen | Instrumentation Laboratory CO | 1998 | — |
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 LJO? 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 LJO device
- #1 K203612 Capture-CMVscore 1.3 · 2 generations · 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 |
|---|---|---|---|
| * | K841520 | CMV Latex Agglutination Test KitSummary page 1…MVgen Classification name(s): 866.3175 Cytomegalovirus serological reagents Class II 83LJO Antigen, IHA, Cytomegalovirus Identification of predicate device(s): CMVscan K841520 Description of the device/intended use(s): CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qu… | 1984 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LJO devicesLJO Antigen, Iha, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJO
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LJO
Too few LJO 510(k)s in any year since 2007 to give a median.
Recalls per year · LJO
No recall names LJO since 2007.
Adverse event reports per year · LJO
1in 2018
MAUDE reports naming product code LJO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma to determine prior exposure to cytomegalovirus.
This assay has not been FDA cleared for use in screening blood or plasma donors.
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/K974456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974456: Cmvgen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974456
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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