510(k) · Cleared
ClearedArchitect CMV IgG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Oct 27, 2022 as substantially equivalent to K181213 (Siemens Healthcare Diagnostics, Inc., 2018) and 1 other predicate after a 209-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Oct 27, 2022
- Review
- 209 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920661 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 |
|---|---|---|---|
| * | K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSummary page 5…lass I, 510(k) Exempt Classification Name: Control Governing Regulation: 21 CFR § 862.1660 Code: JJX III. Predicate Device ADVIA Centaur CMV IgG Assay (K181213) ARCHITECT CMV IgG 510(k)… | 2018 |
| * | K920661 | Vidas CMV Igg AssaySummary page 19…emarket notification demonstrate that the subject device (ARCHITECT CMV IgG) performance is substantially equivalent to the predicate assay (VIDAS CMV IgG assay, k920661). ARCHITECT CMV IgG 510(k)… | 1993 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 25.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2022, 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 ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the ARCHITECT i System. The ARCHITECT CMV IgG assay is to be used as an aid in the diagnosis of infection with cytomegalovirus and as an aid in the determination of serological…
Read the full statement (168 words)
The ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the ARCHITECT i System.
The ARCHITECT CMV IgG assay is to be used as an aid in the diagnosis of infection with cytomegalovirus and as an aid in the determination of serological status to cytomegalovirus in individuals including women of child-bearing age.
The ARCHITECT CMV IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.
The ARCHITECT CMV IgG Calibrators are for the calibration of the ARCHITECT i System when used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum and plasma.
The ARCHITECT CMV IgG Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220949: Architect CMV IgG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220949
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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