Cleared Traditional

K083463 - DIMENSION VISTA BETA 2 MICROGLOBULIN

K083463 is an FDA 510(k) clearance for DIMENSION VISTA BETA 2 MICROGLOBULIN, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K083463 · Siemens Healthcare Diagnostics · Immunology device
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Mar 2009
Decision
109d
Days
Class 2
Risk

K083463 is an FDA 510(k) clearance for the DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, D.... Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on March 13, 2009 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K083463

510(k) Number K083463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date March 13, 2009
Days to Decision 109 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 104d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZG Device Classification - Class 2, Special Controls

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 Immunology devices follow this clearance model.

Regulatory Peers - JZG System, Test, Beta-2-microglobulin Immunological

All 44
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K083463.
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
K122066 · The Binding Site Group , Ltd. · Aug 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
HUMAN BETA-2 MICROGLOBULIN KIT
K083289 · The Binding Site, Ltd. · May 2009
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · Biokit, S.A. · Dec 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
K063272 · Dade Behring, Inc. · Jan 2007
QUANTIA BETA-2 MICROGLOBULIN
K050613 · Biokit, S.A. · Aug 2005