Cleared Traditional

K920525 - BIOTRACK THERAPEUTIC DRUG MONITORING QU...

K920525 is the FDA 510(k) clearance for BIOTRACK THERAPEUTIC DRUG MONITORING QU... by Biotrack, Inc.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K920525 · Biotrack, Inc. · Toxicology device
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Aug 1992
Decision
183d
Days
Class 2
Risk

K920525 is an FDA 510(k) clearance for the BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 183 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K920525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1992
Decision Date August 05, 1992
Days to Decision 183 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
96d slower than avg
Panel avg: 87d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DIS Enzyme Immunoassay, Barbiturate

All 68
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K920525.
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993
BARBITURATE EIA TEST
K925491 · Diagnostic Reagents, Inc. · Dec 1992
IL TEST BARBITURATE, 35289
K920417 · Instrumentation Laboratory CO · Apr 1992
DRUG OF ABUSE ANALYSIS SYSTEM
K903825 · Technicon Instruments Corp. · Sep 1990
EMIT(R) II BARBITURATE ASSAY
K902580 · Syva Co. · Jul 1990