Cleared Abbreviated

K033165 - PRECISET DAT AMPHETAMINE CALIBRATORS

Also marketed or referenced as:
CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS

K033165 is the FDA 510(k) clearance for PRECISET DAT AMPHETAMINE CALIBRATORS by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Abbreviated 510(k) pathway after a 14-day FDA review.

K033165 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
14d
Days
Class 2
Risk

K033165 is an FDA 510(k) clearance for the PRECISET DAT AMPHETAMINE 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 October 14, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - the FDA in vitro diagnostics and chemistry 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

Submission Details

510(k) Number K033165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 14, 2003
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 87
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K033165.
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 THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · Roche Diagnostics Corp. · Dec 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp. · Feb 2003
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · Dade Behring, Inc. · May 2002
DRI ECSTASY URINE CALIBRATORS
K012109 · Microgenics Corp. · Aug 2001