Cleared Special

EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 (K010960) - FDA 510(k) Clearance

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

K010960 · Syva Co., Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
27d
Days
Class 2
Risk

K010960 is an FDA 510(k) clearance for the EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 27 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 Syva Co., Dade Behring, Inc. devices

Submission Details

510(k) Number K010960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date April 26, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 87d · This submission: 27d
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 K010960.
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
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
K061792 · Dade Behring, Inc. · Jul 2006
EMIT ETHYL ALCOHOL ASSAY
K903153 · Syva Co. · Aug 1990