Cleared Traditional

K073390 - DIASORIN LIASON RUBELLA IGG ASSAY

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

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

K073390 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K073390

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.

LFX Device Classification - Class 2, Special Controls

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 79
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