Cleared Traditional

DRUG STOP (K991465) - FDA 510(k) Clearance

K991465 · Texas Immunology, Inc. · Toxicology device
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Dec 1999
Decision
227d
Days
-
Risk

K991465 is an FDA 510(k) clearance for the DRUG STOP. Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on December 10, 1999 after a review of 227 days - an extended review cycle.

This device falls under the Toxicology FDA review panel. 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 Texas Immunology, Inc. devices

Submission Details

510(k) Number K991465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1999
Decision Date December 10, 1999
Days to Decision 227 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
140d slower than avg
Panel avg: 87d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class -