# K202755: Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin Molecular, LLC
- Decided: Nov 5, 2022 after 775 days
- Product code: QDZ (Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection)
- Device class: 2
- Regulation: 21 CFR 866.3181
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180040 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180040: Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit, Meridian Bioscience, Inc. (2018) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K202755
Methodology: https://510kreport.com/methodology