De Novo · Granted
GrantedAlethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Granted on Nov 30, 2018 as a new device type through De Novo after a 123-day review. 1 later device descends from it.
- Decided
- Nov 30, 2018
- Review
- 123 days
- Class
- Class II
- Product code
- QDZ
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN180040 Alethia CMV DNA Amplification Assay, Alethia CMV External Control KitMeridian Bioscience, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK202755 Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive…Diasorin Molecular, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackDiasorin Molecular, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Meridian Bioscience, Inc. | 2018 | — |
| +1 | K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Diasorin Molecular, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA De Novo 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 QDZ? 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 QDZ device
- #1 K202755 Simplexa Congenital CMV Direct and Simplexa…score 4.3 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | 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?
- Of its descendants, K202755 (Diasorin Molecular, LLC, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QDZ devicesQDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QDZ
Too few QDZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QDZ
No recall names QDZ since 2007.
Adverse event reports per year · QDZ
No MAUDE report names QDZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alethia CMV Assay Test System includes separately provided test kits for the Alethia CMV DNA Amplification Assay and the Alethia CMV External Control Reagents. The Alethia CMV DNA Amplification Assay, performed on the Alethia instrument, is a qualitative, in vitro diagnostic test system for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. The test is used as an aid in the diagnosis of…
Read the full statement (181 words)
The Alethia CMV Assay Test System includes separately provided test kits for the Alethia CMV DNA Amplification Assay and the Alethia CMV External Control Reagents.
The Alethia CMV DNA Amplification Assay, performed on the Alethia instrument, is a qualitative, in vitro diagnostic test system for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. The test is used as an aid in the diagnosis of congenital CMV infection. The results of this test should be used in conjunction with the results of other clinical findings.
Flocked swabs should be used to collect saliva from neonates. The swab can be collected dry, without viral transport media (VTM), or placed in no more than 1 mL VTM.
The Alethia CMV External Control Reagents are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors. The external controls are intended for use with the Alethia CMV DNA Amplification Assay; the controls are not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180040: Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180040
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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