Cleared Abbreviated

K033246 - PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS

K033246 is an FDA 510(k) clearance for PRECISET DAT THC AND PRECISET DAT THC 2..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K033246 · Roche Diagnostics Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Dec 2003
Decision
56d
Days
Class 2
Risk

K033246 is an FDA 510(k) clearance for the PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 2, 2003 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K033246

510(k) Number K033246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2003
Decision Date December 02, 2003
Days to Decision 56 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

DLJ Device Classification - Class 2, Special Controls

Product Code DLJ Calibrators, Drug Specific
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.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K033246.
DIMENSION TACR CALIBRATOR, MODEL DC107
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DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108 · Dade Behring, Inc. · Feb 2006
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
K052015 · Dade Behring, Inc. · Sep 2005
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · Roche Diagnostics Corp. · Oct 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp. · Feb 2003
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K023316 · Lin-Zhi International, Inc. · Dec 2002