Cleared Traditional

K934498 - DOA LIQUID DRUGS OF ABUSE CONTROLS (FDA 510(k) Clearance)

Class I Chemistry device.

K934498 · Medical Analysis Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
294d
Days
Class 1
Risk

K934498 is an FDA 510(k) clearance for the DOA LIQUID DRUGS OF ABUSE 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 July 6, 1994 after a review of 294 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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. Standard predicate reliance. 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K934498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1993
Decision Date July 06, 1994
Days to Decision 294 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
206d slower than avg
Panel avg: 88d · This submission: 294d
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.