Cleared Special

K062024 - DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

K062024 is an FDA 510(k) clearance for DIMENSION VISTA DIGITOXIN, manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code LFM cleared through the Special 510(k) pathway after a 10-day FDA review.

K062024 · Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
10d
Days
Class 2
Risk

K062024 is an FDA 510(k) clearance for the DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTO.... Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 28, 2006 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3300 - the FDA toxicology device 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.

FDA 510(k) Submission Details - K062024

510(k) Number K062024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2006
Decision Date July 28, 2006
Days to Decision 10 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 87d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

LFM Device Classification - Class 2, Special Controls

Product Code LFM Enzyme Immunoassay, Digitoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
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 Toxicology devices follow this clearance model.

Regulatory Peers - LFM Enzyme Immunoassay, Digitoxin

All 19
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K062024.
RANDOX DIGITOXIN
K012112 · Randox Laboratories, Ltd. · Jan 2002
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · Dade Behring, Inc. · Mar 1999
ACS DIGITOXIN
K970546 · Chiron Diagnostics Corp. · Jul 1997
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · Abbott Laboratories · Sep 1996
AXSYM DIGITOXIN
K954420 · Abbott Laboratories · Dec 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · Bayer Corp. · Jun 1995
K062024 · DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
Download PDF FDA Summary Dade Behring, Inc.