Cleared Traditional

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (K030211) - FDA 510(k) Clearance

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

K030211 · Icn Biomedicals, Inc. · Toxicology device
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Jun 2003
Decision
143d
Days
Class 2
Risk

K030211 is an FDA 510(k) clearance for the RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016. Classified as Thin Layer Chromatography, Barbiturate (product code DKX), Class II - Special Controls.

Submitted by Icn Biomedicals, Inc. (Burlingame, US). The FDA issued a Cleared decision on June 13, 2003 after a review of 143 days - within the typical 510(k) review window.

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 Icn Biomedicals, Inc. devices

Submission Details

510(k) Number K030211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date June 13, 2003
Days to Decision 143 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 87d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKX Thin Layer Chromatography, 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.