Cleared Traditional

K003412 - ADVIA CENTAUR RUBELLA IGG ASSAY

K003412 is an FDA 510(k) clearance for ADVIA CENTAUR RUBELLA IGG ASSAY, manufactured by Bayer Corp.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K003412 · Bayer Corp. · Microbiology device
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Apr 2001
Decision
162d
Days
Class 2
Risk

K003412 is an FDA 510(k) clearance for the ADVIA CENTAUR RUBELLA IGG ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on April 13, 2001 after a review of 162 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 Bayer Corp. devices

FDA 510(k) Submission Details - K003412

510(k) Number K003412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2000
Decision Date April 13, 2001
Days to Decision 162 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
60d slower than avg
Panel avg: 102d · This submission: 162d
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 63
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K003412.
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · Beckman Coulter, Inc. · Jun 2003
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077 · Diagnostic Products Corp. · Jan 2002
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · Bayer Corp. · Jul 2001
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · Diamedix Corp. · Aug 2000
COPALIS RUBELLA IGM
K993291 · DiaSorin, Inc. · Feb 2000
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · Zeus Scientific, Inc. · Jul 1999