Cleared Traditional

K073390 - DIASORIN LIASON RUBELLA IGG ASSAY

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

K073390 is the FDA 510(k) clearance for DIASORIN LIASON RUBELLA IGG ASSAY by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 354-day FDA review.

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
Combination Product No
PCCP Authorized No
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 62
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K073390.
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · Roche Diagnostics · Mar 2010
VIDAS RUB IGG
K080766 · bioMerieux, Inc. · Dec 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · Roche Diagnostics Corp. · Dec 2008
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
K063186 · Zeus Scientific, Inc. · Mar 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
K063143 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · Beckman Coulter, Inc. · Jun 2003