Cleared Traditional

K041666 - DC-ACETA/SAL CONTROLS

K041666 is the FDA 510(k) clearance for DC-ACETA/SAL CONTROLS by Diagnostic Chemicals , Ltd.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K041666 · Diagnostic Chemicals , Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
60d
Days
Class 1
Risk

K041666 is an FDA 510(k) clearance for the DC-ACETA/SAL CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, Prince Edward, CA). The FDA issued a Cleared decision on August 17, 2004 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K041666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date August 17, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 87d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K041666.
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · Bio-Rad Laboratories, Inc. · Apr 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · Biosite Incorporated · Mar 2005
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · Bio-Rad · Nov 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · Bio-Rad · Jul 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · Microgenics Corp. · May 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · Bio-Rad Laboratories, Inc. · Feb 2004