Cleared Traditional

K121247 - ALCO-SCREEN

K121247 is an FDA 510(k) clearance for ALCO-SCREEN, manufactured by Chematics, Inc.. The device is a Class 2 Chemistry device with product code DIC cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K121247 · Chematics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
331d
Days
Class 2
Risk

K121247 is an FDA 510(k) clearance for the ALCO-SCREEN. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Chematics, Inc. (North Webster, US). The FDA issued a Cleared decision on March 22, 2013 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Chematics, Inc. devices

FDA 510(k) Submission Details - K121247

510(k) Number K121247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2012
Decision Date March 22, 2013
Days to Decision 331 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 88d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIC Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K121247.
Sober Self-Test
K250609 · Sober Ip, LLC · Sep 2025
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · Immunalysis Corporation · Oct 2018
ALCO-SCREEN 02
K121256 · Chematics, Inc. · Sep 2012
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
K111005 · Medica Corp. · Nov 2011
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K111206 · Teco Diagnostics · Oct 2011
RANDOX ETHANOL ASSAY
K092273 · Randox Laboratories, Ltd. · Nov 2010