Cleared Traditional

K942552 - THERAPEUTIC DRUG MONITORING CONTROL

K942552 is the FDA 510(k) clearance for THERAPEUTIC DRUG MONITORING CONTROL by Medi-Tech, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K942552 · Medi-Tech, Inc. · Toxicology device
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Sep 1994
Decision
101d
Days
Class 1
Risk

K942552 is an FDA 510(k) clearance for the THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Medi-Tech, Inc. (Ventura, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 101 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K942552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date September 09, 1994
Days to Decision 101 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
14d slower than avg
Panel avg: 87d · This submission: 101d
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 112
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K942552.
DRUGS OF ABUSE CONTROLS
K950138 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · Roche Diagnostic Systems, Inc. · Jan 1995
ABUSCREEN ONLINE CONTROLS
K945194 · Roche Diagnostic Systems, Inc. · Dec 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · Roche Diagnostic Systems, Inc. · Sep 1994
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