Cleared Traditional

K092322 - ELECSYS RUBELLA IGM IMMUNOASSAY

K092322 is an FDA 510(k) clearance for ELECSYS RUBELLA IGM IMMUNOASSAY, manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K092322 · Roche Diagnostics · Microbiology device
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Mar 2010
Decision
220d
Days
Class 2
Risk

K092322 is an FDA 510(k) clearance for the ELECSYS RUBELLA IGM IMMUNOASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 12, 2010 after a review of 220 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Roche Diagnostics devices

FDA 510(k) Submission Details - K092322

510(k) Number K092322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date March 12, 2010
Days to Decision 220 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
118d slower than avg
Panel avg: 102d · This submission: 220d
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 K092322.
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K122397 · DiaSorin, Inc. · Sep 2012
MAGO 4S
K093101 · Diamedix Corp. · Jan 2011
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
K092587 · Bio-Rad Laboratories · Dec 2010
VIDAS RUB IGG
K080766 · bioMerieux, Inc. · Dec 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · Roche Diagnostics Corp. · Dec 2008
DIASORIN LIASON RUBELLA IGG ASSAY
K073390 · DiaSorin, Inc. · Nov 2008