510(k) · Cleared
ClearedSimplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin Molecular, LLC · QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Cleared on Nov 5, 2022 as substantially equivalent to DEN180040 (Meridian Bioscience, Inc., 2018) after a 775-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Nov 5, 2022
- Review
- 775 days
- Class
- Class II
- Product code
- QDZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180040 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180040 Alethia CMV DNA Amplification Assay, Alethia CMV External Control KitMeridian Bioscience, Inc. · 2018
- This deviceK202755 Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive…Diasorin Molecular, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Meridian Bioscience, Inc. | 2018 | — |
| 0 (this device) | K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Diasorin Molecular, LLC | 2022 | — |
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 QDZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control KitSummary page 4…mentation for clinical multiplex test systems 21 CFR § 862.2570 Classification Class II Predicate Devices Alethia® CMV Assay Test System DEN180040 (for saliva swab). Currently, there is not a predicate device for urine as a compatible specimen… | 2018 |
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?
- Its one ancestor has no recall.
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. 2022, 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 DiaSorin Molecular Simplexa™ Congenital CMV Direct is a real-time PCR assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of cytomegalovirus (CMV) from saliva swabs and urine from infants less than 21 days of age. Positive results from saliva are presumptive and should be confirmed with urine. The results of the Simplexa™ Congenital CMV Direct assay should be used in conjunction with the results of other…
Read the full statement (156 words)
The DiaSorin Molecular Simplexa™ Congenital CMV Direct is a real-time PCR assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of cytomegalovirus (CMV) from saliva swabs and urine from infants less than 21 days of age. Positive results from saliva are presumptive and should be confirmed with urine. The results of the Simplexa™ Congenital CMV Direct assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection.
This test has not been cleared for screening of blood or blood products for the presence of CMV or for use with samples other than urine and saliva swabs
DiaSorin Molecular’s Simplexa™ Congenital CMV Positive Control Pack is intended to be used as a control with the Simplexa Congenital CMV Direct kit for use on the LIAISON MDX instrument. This control is not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202755: Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202755
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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