Cleared Special

K031606 - ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY

K031606 is an FDA 510(k) clearance for ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Special 510(k) pathway after a 29-day FDA review.

K031606 · Beckman Coulter, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
29d
Days
Class 2
Risk

K031606 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 20, 2003 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031606

510(k) Number K031606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2003
Decision Date June 20, 2003
Days to Decision 29 days
Submission Type Special
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
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 93
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K031606.
DIASORIN LIASON RUBELLA IGG ASSAY
K073390 · DiaSorin, Inc. · Nov 2008
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
K063186 · Zeus Scientific, Inc. · Mar 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
K063143 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
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
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · Bayer Corp. · Apr 2001
K031606 · ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
Download PDF FDA Summary Beckman Coulter, Inc.