510(k) · Cleared
Recalled · Class II · 2015Diamedix IS-CMV Igg Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamedix Corp. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Sep 21, 1998 after a 174-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 1998
- Review
- 174 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981163 | Diamedix IS-CMV Igg Test System | Diamedix Corp. | 1998 | — |
| +1 | K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay | Roche Diagnostics | 2014 | — |
| +2 | K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 LFZ? 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 LFZ device
- #1 K220911 Elecsys CMV IgGscore 4.8 · 3 generations · 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 |
|---|---|---|---|
| * | — | Incstar CMV IgG ELISA Kit Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2015 | Class II | Z-1689-2016 | Other | Product contained an incorrect substrate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131605 (Roche Diagnostics, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LFZ devicesLFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFZ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LFZ
Too few LFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFZ
53in 2025
MAUDE reports naming product code LFZ, 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 | 7 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 1 | 14 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 2 | — | 0 | 13 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 2 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 1 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diamedix Is-CMV I9G an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of primary infection, reactivated infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with the MAGO® Plus Aulomated EIA Processor.
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/K981163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981163: Diamedix IS-CMV Igg Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981163
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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