Cleared Special

K061793 - DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR

K061793 is an FDA 510(k) clearance for DIMENSION VISTA IRON FLEX REAGENT CARTR..., manufactured by Dade Behring, Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Special 510(k) pathway after a 42-day FDA review.

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

FDA 510(k) Submission Details - K061793

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.

JIY Device Classification - Class 1, General Controls

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.

Regulatory Peers - JIY Photometric Method, Iron (non-heme)

All 60
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K061793.
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · Dade Behring, Inc. · Mar 2006
VITALAB IRON REAGENT
K033983 · Clinical Data, Inc. · May 2004
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · Diagnostic Chemicals , Ltd. · May 2002
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · Wiener Laboratories Saic · Nov 2001
IRON
K981241 · Abbott Laboratories · May 1998
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · Diagnostic Chemicals , Ltd. · Nov 1997