Cleared Traditional

URINE TOXICOLOGY STANDARD (K881320) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881320 · Verichem Laboratories, Inc. · Toxicology device
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Sep 1988
Decision
165d
Days
Class 2
Risk

K881320 is an FDA 510(k) clearance for the URINE TOXICOLOGY STANDARD. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Verichem Laboratories, Inc. (East Providence, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 165 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Verichem Laboratories, Inc. devices

Submission Details

510(k) Number K881320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date September 09, 1988
Days to Decision 165 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 87d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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.