510(k) · Cleared
ClearedElecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm
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 Oct 24, 2014 as substantially equivalent to K001767 (Diamedix Corp., 2000) and 1 other predicate after an 81-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Oct 24, 2014
- Review
- 81 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931172 (1993). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 5 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 4 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 3 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 2 generations backK031990 Elecsys Precicontrol Troponin TRoche Diagnostics Corp. · 2003
- 1 generation backK092322 Elecsys Rubella Igm ImmunoassayRoche Diagnostics · 2010
- This deviceK142133 Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK163569 Elecsys CMV IgMRoche Diagnostics · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K163569Elecsys CMV IgMRoche Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −5 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −2 | K031990 | Elecsys Precicontrol Troponin T | Roche Diagnostics Corp. | 2003 | — |
| −1 | K092322 | Elecsys Rubella Igm Immunoassay | Roche Diagnostics | 2010 | — |
| 0 (this device) | K142133 | Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm | Roche Diagnostics | 2014 | — |
| +1 | K163569 | Elecsys CMV IgM | Roche Diagnostics | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K001767 | Diamedix IS-CMV Igm Capture Test SystemSummary page 4…Unassayed) Product Code: (1) LFZ (2) JJX Predicate Device: (1) Diamedix Is-CMV IgM Capture Test Kit (K001767) (2) Elecsys PreciControl Rubella IgM (K092322)… | 2000 |
| * | K092322 | Elecsys Rubella Igm ImmunoassaySummary page 4…(2) JJX Predicate Device: (1) Diamedix Is-CMV IgM Capture Test Kit (K001767) (2) Elecsys PreciControl Rubella IgM (K092322) Page 1 of 17 Roche… | 2010 |
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 |
|---|---|---|---|
| K163569 | Elecsys CMV IgM | 2017 | 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 21 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K163569 (Roche Diagnostics, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K001767.
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?
(1) Immunoassay for the in vitro qualitative detection of IgM 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 diagnosis of recent or current CMYV infection in individuals for which a CMV IgM test was ordered, including pregnant women. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use…
Read the full statement (129 words)
(1) Immunoassay for the in vitro qualitative detection of IgM 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 diagnosis of recent or current CMYV infection in individuals for which a CMV IgM 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 assay is not intended for use in screening blood and plasma donors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys immunoassay analyzers.
(2) PreciControl CMV IgM is used for quality control of the Elecsys CMV IgM 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/K142133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142133: Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142133
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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