Cleared Traditional

K063322 - DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE

K063322 is the FDA 510(k) clearance for DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE by Dade Behring, Inc.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K063322 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
82d
Days
Class 2
Risk

K063322 is an FDA 510(k) clearance for the DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CO.... Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 24, 2007 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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 K063322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2006
Decision Date January 24, 2007
Days to Decision 82 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
22d faster than avg
Panel avg: 104d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 35
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K063322.
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
K080634 · Beckman Coulter, Inc. · Aug 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
K081299 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K063663 · Dade Behring, Inc. · Mar 2007
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · Dade Behring, Inc. · Mar 2006
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
K042477 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
TINA-QUANT TRANSFERRIN VER.2
K012371 · Roche Diagnostics Corp. · Sep 2001