Cleared Traditional

K942041 - NIDA-5/RT, DRUG OF ABUSE CONTROLS

K942041 is an FDA 510(k) clearance for NIDA-5/RT, manufactured by Meditech. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K942041 · Meditech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
139d
Days
Class 1
Risk

K942041 is an FDA 510(k) clearance for the NIDA-5/RT, DRUG OF ABUSE CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Meditech (Ventura, US). The FDA issued a Cleared decision on September 14, 1994 after a review of 139 days - within the typical 510(k) review window.

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 Meditech devices

FDA 510(k) Submission Details - K942041

510(k) Number K942041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date September 14, 1994
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 87d · This submission: 139d
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 177
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K942041.
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · Roche Diagnostic Systems, Inc. · Jan 1995
ABUSCREEN ONLINE CONTROLS
K945194 · Roche Diagnostic Systems, Inc. · Dec 1994
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551 · Medi-Tech, Inc. · Oct 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · Medical Diagnostic Technologies, Inc. · Sep 1994
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
K942552 · Medi-Tech, Inc. · Sep 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · Roche Diagnostic Systems, Inc. · Sep 1994