Cleared Traditional

K110169 - DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110169 · Siemens Healthcare Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 2011
Decision
77d
Days
Class 2
Risk

K110169 is an FDA 510(k) clearance for the DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 7, 2011 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K110169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2011
Decision Date April 07, 2011
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

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.