Cleared Traditional

ROCHE REAGENT FOR ETHANOL (K913125) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913125 · Roche Diagnostic Systems, Inc. · Chemistry device
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Aug 1991
Decision
28d
Days
Class 2
Risk

K913125 is an FDA 510(k) clearance for the ROCHE REAGENT FOR ETHANOL. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3040 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K913125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1991
Decision Date August 12, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Chemistry 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 K913125.
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