Cleared Traditional

BIOTRACK THEOPHYLLINE QUALITY CONTROLS (K903924) - FDA 510(k) Clearance

Class I Toxicology device.

K903924 · Biotrack, Inc. · Toxicology device
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Sep 1990
Decision
24d
Days
Class 1
Risk

K903924 is an FDA 510(k) clearance for the BIOTRACK THEOPHYLLINE QUALITY CONTROLS. Classified as Theophylline Control Materials (product code LAW), Class I - General Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 24 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biotrack, Inc. devices

Submission Details

510(k) Number K903924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1990
Decision Date September 17, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAW Theophylline 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.