Cleared Special

DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061793) - FDA 510(k) Clearance

Class I Chemistry device.

K061793 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
42d
Days
Class 1
Risk

K061793 is an FDA 510(k) clearance for the DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 7, 2006 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K061793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date August 07, 2006
Days to Decision 42 days
Submission Type Special
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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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.