Cleared Traditional

SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (K971506) - FDA 510(k) Clearance

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

K971506 · Beckman Instruments, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
39d
Days
Class 2
Risk

K971506 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR. Classified as Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet (product code DMT), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 3, 1997 after a review of 39 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. 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K971506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date June 03, 1997
Days to Decision 39 days
Submission Type Traditional
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
48d faster than avg
Panel avg: 87d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
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 - DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Devices cleared under the same product code (DMT) and FDA review panel - the closest regulatory comparables to K971506.
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410 · Beckman Coulter, Inc. · Apr 2000
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
K934273 · Eastman Kodak Company · Mar 1994
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · Em Diagnostic Systems, Inc. · Jan 1987
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL ASSAY
K802621 · Syva Co. · Oct 1980