Cleared Traditional

K082251 - SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT

K082251 is the FDA 510(k) clearance for SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code DCF) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K082251 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
243d
Days
Class 2
Risk

K082251 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 243 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K082251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date April 08, 2009
Days to Decision 243 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 88d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCF Albumin, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K082251.
TINA-QUANT ALBUMIN GEN 2
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K091486 · Kamiya Biomedical Co. · Apr 2010
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · Dade Behring, Inc. · Sep 2006
DCL MICROALBUMIN ASSAY, MODEL 252-20
K051191 · Diagnostic Chemicals , Ltd. · Jul 2005
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
K042643 · Ortho-Clinical Diagnostics, Inc. · Nov 2004