Cleared Traditional

K181305 - OralTox Oral fluid Drug Test

K181305 is the FDA 510(k) clearance for OralTox Oral fluid Drug Test by Premier Biotech, Inc.. It is a Class 2 Toxicology device (product code DJC) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K181305 · Premier Biotech, Inc. · Toxicology device
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Sep 2018
Decision
126d
Days
Class 2
Risk

K181305 is an FDA 510(k) clearance for the OralTox Oral fluid Drug Test. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Premier Biotech, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 20, 2018 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 Premier Biotech, Inc. devices

Submission Details

510(k) Number K181305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2018
Decision Date September 20, 2018
Days to Decision 126 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
39d slower than avg
Panel avg: 87d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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.

Regulatory Peers - DJC Thin Layer Chromatography, Methamphetamine

All 14
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