Cleared Traditional

K063508 - DIMENSION VISTA PROTEIN 1 CALIBRATOR AN...

Also marketed or referenced as:
PROTEIN 2 CALIBRATOR AND CONTROL L, H PROTEIN 3 CALIBRATOR AN

K063508 is the FDA 510(k) clearance for DIMENSION VISTA PROTEIN 1 CALIBRATOR AN... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K063508 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
64d
Days
Class 2
Risk

K063508 is an FDA 510(k) clearance for the DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 23, 2007 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: 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 K063508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2006
Decision Date January 23, 2007
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 175
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K063508.
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · Dade Behring, Inc. · Oct 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
K071801 · Ortho-Clinical Diagnostics, Inc. · Jul 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207 · Pointe Scientific, Inc., · Apr 2007
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · Dade Behring, Inc. · Oct 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · Dade Behring, Inc. · Sep 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · Roche Diagnostics Corp. · Sep 2006