Cleared Traditional

K092322 - ELECSYS RUBELLA IGM IMMUNOASSAY

K092322 is the FDA 510(k) clearance for ELECSYS RUBELLA IGM IMMUNOASSAY by Roche Diagnostics. It is a Class 2 Microbiology device (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

Submission Details

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.

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 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