Cleared Traditional

K934650 - CEDIA DAU CONTROLS

K934650 is an FDA 510(k) clearance for CEDIA DAU CONTROLS, manufactured by Medical Analysis Systems, Inc.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K934650 · Medical Analysis Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
209d
Days
Class 1
Risk

K934650 is an FDA 510(k) clearance for the CEDIA DAU CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 209 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Analysis Systems, Inc. devices

FDA 510(k) Submission Details - K934650

510(k) Number K934650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date April 26, 1994
Days to Decision 209 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
122d slower than avg
Panel avg: 87d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K934650.
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4
K940433 · Medical Analysis Systems, Inc. · Jul 1994
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
K936166 · Medical Analysis Systems, Inc. · Jul 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS
K934498 · Medical Analysis Systems, Inc. · Jul 1994
DRUGS OF ABUSE CONTROLS
K935285 · Medical Diagnostic Technologies, Inc. · Mar 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
K934062 · Biotrack, Inc. · Dec 1993