Cleared Traditional

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (K122397) - FDA 510(k) Clearance

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

K122397 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 93
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K122397.
Access Rubella IgG
K250588 · Beckman Coulter, Inc. · Nov 2025
Alinity i Rubella IgG
K243168 · Abbott Laboratories · Jun 2025
RUBASCAN CARD TEST
K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · Abbott Laboratories · Sep 1996
IMX RUBELLA IGG
K951541 · Abbott Laboratories · Jul 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · Abbott Laboratories · May 1996