Cleared Traditional

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (K931227) - FDA 510(k) Clearance

Class I Toxicology device.

K931227 · U.S. Drug Testing, Inc. · Toxicology device
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May 1993
Decision
57d
Days
Class 1
Risk

K931227 is an FDA 510(k) clearance for the USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000. Classified as Chromatography (liquid, Gel), Clinical Use (product code KZR), Class I - General Controls.

Submitted by U.S. Drug Testing, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 6, 1993 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - 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 U.S. Drug Testing, Inc. devices

Submission Details

510(k) Number K931227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date May 06, 1993
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZR Chromatography (liquid, Gel), Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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.