Cleared Traditional

K260770 - LIAISON Murex HBsAg Qual (FDA 510(k) Clearance)

Also includes:
LIAISON XL LIAISON diluteX
K260770 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
87d
Days
-
Risk

K260770 is an FDA 510(k) clearance for the LIAISON Murex HBsAg Qual.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on June 4, 2026 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K260770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2026
Decision Date June 04, 2026
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOM
Device Class -