Cleared Traditional

K063351 - DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH

K063351 is an FDA 510(k) clearance for DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K063351 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
77d
Days
Class 2
Risk

K063351 is an FDA 510(k) clearance for the DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATI.... Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 22, 2007 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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.

FDA 510(k) Submission Details - K063351

510(k) Number K063351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date January 22, 2007
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDY Device Classification - Class 2, Special Controls

Product Code NDY Test, Cystatin C
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - NDY Test, Cystatin C

All 21
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K063351.
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
K072166 · The Binding Site · Jan 2008
GENTIAN CYSTATIN C IMMUNOASSAY
K071388 · Gentian AS · Nov 2007
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
K063647 · Thermo Electron OY · Mar 2007
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
K041627 · Dako A/S · Sep 2004
N LATEX CYSTATIN
K041878 · Dade Behring, Inc. · Aug 2004
N LATEX CYSTATIN C
K003503 · Dade Behring, Inc. · Mar 2001
K063351 · DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
Download PDF FDA Summary Dade Behring, Inc.