Cleared Special

DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI (K061792) - FDA 510(k) Clearance

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

K061792 · Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
22d
Days
Class 2
Risk

K061792 is an FDA 510(k) clearance for the DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0.... Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - 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 K061792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date July 18, 2006
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
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 - DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

All 32
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K061792.
Sober Self-Test
K250609 · Sober Ip, LLC · Sep 2025
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · Immunalysis Corporation · Oct 2018
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · Dade Behring, Inc. · Aug 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · Dade Behring, Inc. · Jun 2007
EMIT ETHYL ALCOHOL ASSAY
K903153 · Syva Co. · Aug 1990
AD X(TM) ETHANOL
K890743 · Abbott Laboratories · Aug 1989