Cleared Traditional

K063272 - DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH

K063272 is an FDA 510(k) clearance for DIMENSION VISTA B2MIC FLEX REAGENT CART..., manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K063272

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
17d faster than avg
Panel avg: 105d · This submission: 88d
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 45
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K063272.
HUMAN BETA-2 MICROGLOBULIN KIT
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
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · Biokit, S.A. · Dec 2007
QUANTIA BETA-2 MICROGLOBULIN
K050613 · Biokit, S.A. · Aug 2005
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · The Binding Site, Ltd. · Aug 2002
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000