Not Cleared Direct

DEN250032 - LIAISON® XL MUREX Anti-HDV (318260) (FDA 510(k) Clearance)

Also includes:
LIAISON® XL MUREX Control Anti-HDV (318261)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250032 · DiaSorin, Inc. · Microbiology device
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Dec 2025
Decision
146d
Days
Class 2
Risk

DEN250032 is an FDA 510(k) submission (not cleared) for the LIAISON® XL MUREX Anti-HDV (318260). Classified as Device To Detect Antibodies To Hepatitis D Virus (product code SGW), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2025 after a review of 146 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3176 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all DiaSorin, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 102d · This submission: 146d
Pathway characteristics

Device Classification

Product Code SGW Device To Detect Antibodies To Hepatitis D Virus
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.