Cleared Traditional

DIASORIN LIASON RUBELLA IGG ASSAY (K073390) - FDA 510(k) Clearance

Also marketed or referenced as:
DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073390 · DiaSorin, Inc. · Microbiology device
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Nov 2008
Decision
354d
Days
Class 2
Risk

K073390 is an FDA 510(k) clearance for the DIASORIN LIASON RUBELLA IGG ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K073390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date November 21, 2008
Days to Decision 354 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 102d · This submission: 354d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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.

Regulatory Peers - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 93
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K073390.
Access Rubella IgG
K250588 · Beckman Coulter, Inc. · Nov 2025
Alinity i Rubella IgG
K243168 · Abbott Laboratories · Jun 2025
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077 · Diagnostic Products Corp. · Jan 2002
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
K982078 · Diagnostic Products Corp. · Dec 1998
IMMULITE RUBELLA IGG
K963613 · Diagnostic Products Corp. · Apr 1997
RUBASCAN CARD TEST
K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1996