DEN250032 is an FDA 510(k) submission for the LIAISON® XL MUREX Anti-HDV (318260). This device is classified as a Device To Detect Antibodies To Hepatitis D Virus (Class II - Special Controls, product code SGW).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3176. The Device To Detect Antibodies To Hepatitis D Virus Is An In Vitro Diagnostic Device Intended For Prescription Use For The Detection Of Antibodies To The Hepatitis D Virus (anti-hdv) In Human Clinical Specimens. The Assay Is Intended As An Aid In The Diagnosis Of Hdv Infection In Individuals Who Are At Risk For Hdv Infection. The Assay Is Intended As An Aid In Diagnosis In Conjunction With Clinical Findings And Other Diagnostic Procedures. The Assay Is Not Intended For Screening Of Blood, Plasma, Cells, Or Tissue Donors..
| 510(k) Number | DEN250032 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 30, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 146 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | SGW — Device To Detect Antibodies To Hepatitis D Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3176 |
| Definition | The Device To Detect Antibodies To Hepatitis D Virus Is An In Vitro Diagnostic Device Intended For Prescription Use For The Detection Of Antibodies To The Hepatitis D Virus (anti-hdv) In Human Clinical Specimens. The Assay Is Intended As An Aid In The Diagnosis Of Hdv Infection In Individuals Who Are At Risk For Hdv Infection. The Assay Is Intended As An Aid In Diagnosis In Conjunction With Clinical Findings And Other Diagnostic Procedures. The Assay Is Not Intended For Screening Of Blood, Plasma, Cells, Or Tissue Donors. |