Cleared Traditional

K122397 - LIAISON RUBELLA IGM

K122397 is the FDA 510(k) clearance for LIAISON RUBELLA IGM by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K122397 · DiaSorin, Inc. · Microbiology device
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Sep 2012
Decision
30d
Days
Class 2
Risk

K122397 is an FDA 510(k) clearance for the LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM. 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 September 6, 2012 after a review of 30 days - a notably fast clearance cycle.

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: 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 K122397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2012
Decision Date September 06, 2012
Days to Decision 30 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
72d faster than avg
Panel avg: 102d · This submission: 30d
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 59
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K122397.
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K092587 · Bio-Rad Laboratories · Dec 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · Roche Diagnostics · Mar 2010
VIDAS RUB IGG
K080766 · bioMerieux, Inc. · Dec 2008