Cleared Traditional

K072717 - DIMENSION VISTA SYSTEM BILIRUBIN CALIBR...

K072717 is the FDA 510(k) clearance for DIMENSION VISTA SYSTEM BILIRUBIN CALIBR... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K072717 · Dade Behring, Inc. · Chemistry device
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Dec 2007
Decision
78d
Days
Class 2
Risk

K072717 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 12, 2007 after a review of 78 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 K072717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2007
Decision Date December 12, 2007
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 145
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K072717.
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · Siemens Healthcare Diagnostics · Jul 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · Beckman Coulter, Inc. · Mar 2008
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552 · Dade Behring, Inc. · Apr 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144 · Beckman Coulter, Inc. · Feb 2007
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152 · Dade Behring, Inc. · Aug 2006