Cleared Traditional

K060896 - MODIFICATION TO ONTRAK TESTCUP II AND O...

K060896 is the FDA 510(k) clearance for MODIFICATION TO ONTRAK TESTCUP II AND O... by Varian, Inc.. It is a Class 2 Toxicology device (product code DJC) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K060896 · Varian, Inc. · Toxicology device
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Jun 2006
Decision
67d
Days
Class 2
Risk

K060896 is an FDA 510(k) clearance for the MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Varian, Inc. (Lake Forest, US). The FDA issued a Cleared decision on June 9, 2006 after a review of 67 days - a notably fast clearance cycle.

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: 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 Varian, Inc. devices

Submission Details

510(k) Number K060896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date June 09, 2006
Days to Decision 67 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
20d faster than avg
Panel avg: 87d · This submission: 67d
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

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