Cleared Special

DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE (K062024) - FDA 510(k) Clearance

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062024 · Dade Behring, Inc. · Toxicology device
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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.

View all Dade Behring, Inc. devices

Submission Details

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.

Device Classification

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.
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · Dade Behring, Inc. · Mar 1999
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · Abbott Laboratories · Sep 1996
AXSYM DIGITOXIN
K954420 · Abbott Laboratories · Dec 1995
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · Syva Co. · Sep 1994
TDX DIGITOXIN
K842280 · Abbott Laboratories · Aug 1984