Cleared Traditional

K063272 - DIMENSION VISTA B2MIC FLEX REAGENT CART...

K063272 is the FDA 510(k) clearance for DIMENSION VISTA B2MIC FLEX REAGENT CART... by Dade Behring, Inc.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K063272 · Dade Behring, Inc. · Immunology device
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Jan 2007
Decision
88d
Days
Class 2
Risk

K063272 is an FDA 510(k) clearance for the DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL M.... Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K063272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date January 26, 2007
Days to Decision 88 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
16d faster than avg
Panel avg: 104d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K063272.
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
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K083289 · The Binding Site, Ltd. · May 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
K083463 · Siemens Healthcare Diagnostics · Mar 2009
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · The Binding Site, Ltd. · Aug 2002
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
K993711 · Bayer Corp. · Dec 1999