510(k) · Cleared
ClearedElecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Feb 28, 2014 as substantially equivalent to K981163 (Diamedix Corp., 1998) and 1 other predicate after a 270-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Feb 28, 2014
- Review
- 270 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983805 (1999). 4 ancestors in all, the oldest K981163 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983805 The Aptus (Automated) Application of the Rubella Igg Elisa Test…Zeus Scientific, Inc. · 1999
- 1 generation backK072617 Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp. · 2008
- This deviceK131605 Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK220911 Elecsys CMV IgGRoche Diagnostics · 2022
Most influential descendants
Showing 1 of 1 · See all- K220911Elecsys CMV IgGRoche Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an… | Zeus Scientific, Inc. | 1999 | — |
| −1 | K072617 | Elecsys Rubella Igg Immunoassay | Roche Diagnostics Corp. | 2008 | — |
| 0 (this device) | K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay | Roche Diagnostics | 2014 | — |
| +1 | K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 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 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? (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 |
|---|---|---|---|
| * | K981163 | Diamedix IS-CMV Igg Test SystemSummary page 1…nassayed) Product Code: (1) LFZ (2) JJX Predicate Device: (1) Diamedix ls-CMV IgG (K981 163) (2) Elecsys PreciControl Rubella [gO (K0726 17)… | 1998 |
| * | K072617 | Elecsys Rubella Igg ImmunoassaySummary page 1…(2) JJX Predicate Device: (1) Diamedix ls-CMV IgG (K981 163) (2) Elecsys PreciControl Rubella [gO (K0726 17) Continued on next page Confidential… | 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 |
|---|---|---|---|
| K220911 | Elecsys CMV IgG | 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 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K220911 (Roche Diagnostics, 2022) has gone furthest, with 0 descendants 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. 2014, this device’s year, is highlighted.
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 Elecsys CMV IgG assay is an in vitro qualitative test for the detection of IgG antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the determination of the serological status to CMV in individuals in which a CMV IgG test was ordered, including pregnant women. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is…
Read the full statement (138 words)
The Elecsys CMV IgG assay is an in vitro qualitative test for the detection of IgG antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the determination of the serological status to CMV in individuals in which a CMV IgG test was ordered, including pregnant women. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This test is not intended for use in screening blood and plasma donors. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl CMV IgG is used for quality control of the Elecsys CMV IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131605: Elecsys Precicontrol CMV Igg, Elecsys CMV 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/K131605
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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