Cleared Traditional

K063608 - DIMENSION VISTA APOA1 AND APOB FLEX REA...

K063608 is the FDA 510(k) clearance for DIMENSION VISTA APOA1 AND APOB FLEX REA... by Dade Behring, Inc.. It is a Class 1 Chemistry device (product code MSJ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K063608 · Dade Behring, Inc. · Chemistry device
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Feb 2007
Decision
81d
Days
Class 1
Risk

K063608 is an FDA 510(k) clearance for the DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRAT.... Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 K063608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2006
Decision Date February 23, 2007
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSJ Apolipoproteins

All 25
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K063608.
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377 · Pointe Scientific, Inc., · Mar 2007
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · Bayer Corp. · Feb 2000
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · Beckman Instruments, Inc. · Apr 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
K964010 · Beckman Instruments, Inc. · Feb 1997
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · Nichols Institute Diagnostics · Dec 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080 · Instrumentation Laboratory CO · Oct 1992