Cleared Traditional

K934062 - BIOTRACK THERAPEUTIC DRUG-MONITORING QU...

K934062 is the FDA 510(k) clearance for BIOTRACK THERAPEUTIC DRUG-MONITORING QU... by Biotrack, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K934062 · Biotrack, Inc. · Toxicology device
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Dec 1993
Decision
132d
Days
Class 1
Risk

K934062 is an FDA 510(k) clearance for the BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 29, 1993 after a review of 132 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 Biotrack, Inc. devices

Submission Details

510(k) Number K934062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date December 29, 1993
Days to Decision 132 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
45d slower than avg
Panel avg: 87d · This submission: 132d
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 148
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K934062.
CEDIA DAU CONTROLS
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DRUGS OF ABUSE CONTROLS
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EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · Roche Diagnostic Systems, Inc. · Aug 1993
ABUSCREEN ONLINE CONTROL
K931125 · Roche Diagnostic Systems, Inc. · Aug 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · Bio-Rad · Jul 1993