510(k) · Cleared
ClearedADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Jul 30, 2018 as substantially equivalent to K920661 (Vitek Systems, Inc., 1993) after an 84-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Jul 30, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920661 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK920661 Vidas CMV Igg AssayVitek Systems, Inc. · 1993 · Recalled
- This deviceK181213 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK220949 Architect CMV IgGAbbott Laboratories · 2022
Most influential descendants
Showing 1 of 1 · See all- K220949Architect CMV IgGAbbott Laboratories · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920661 | Vidas CMV Igg Assay | Vitek Systems, Inc. | 1993 | 1 |
| 0 (this device) | K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
| +1 | K220949 | Architect CMV IgG | Abbott Laboratories | 2022 | — |
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? (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 |
|---|---|---|---|
| * | K920661 | Vidas CMV Igg AssaySummary page 4…II Product Code: LFZ Panel: Microbiology (83) 4. Predicate Device: Device Name: bioMerieux VIDAS CMV IgG (CMVG) Assay 510(k) Number: k920661 Manufacturer: bioMerieux 5. Indications for Use: ADVIA Centaur CMV lgG: The ADVIA Centaur® CMV IgG Assay is for in vitr… | 1993 |
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 |
|---|---|---|---|
| K220949 | Architect 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?
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. 2018, 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?
ADVIA Centaur® CMV IgG (CMV lgG) assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human pediatric and adult serum and plasma (dipotassium EDTA, lithium heparin) using the ADVIA Centaur XP system. The assay is used to determine CMV lgG serological status and as an aid in the diagnosis of CMV infection in individuals for whom a CMV IgG test was ordered, including pregnant women. The ADVIA…
Read the full statement (122 words)
ADVIA Centaur® CMV IgG (CMV lgG) assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human pediatric and adult serum and plasma (dipotassium EDTA, lithium heparin) using the ADVIA Centaur XP system. The assay is used to determine CMV lgG serological status and as an aid in the diagnosis of CMV infection in individuals for whom a CMV IgG test was ordered, including pregnant women. The ADVIA Centaur CMV IgG assay is not intended for blood and tissue donor screening.
The ADVIA Centaur® CMV IgG (CMV IgG) Quality Control material is for in vitro diagnostic use for monitoring the performance of the ADVIA Centaur CMV IgG (CMV IgG) assay on ADVIA Centaur systems.
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/K181213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181213: ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181213
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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