Cleared Abbreviated

K033306 - PRECISET DAT PLUS II AND CFAS DAT QUALI...

K033306 is the FDA 510(k) clearance for PRECISET DAT PLUS II AND CFAS DAT QUALI... by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code DKB) cleared through the Abbreviated 510(k) pathway after a 62-day FDA review.

K033306 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Dec 2003
Decision
62d
Days
Class 2
Risk

K033306 is an FDA 510(k) clearance for the PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 15, 2003 after a review of 62 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 K033306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date December 15, 2003
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DKB Calibrators, Drug Mixture
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 - DKB Calibrators, Drug Mixture

All 69
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K033306.
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · Dade Behring, Inc. · Aug 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K060645 · Roche Diagnostics Corp. · May 2006
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · Dade Behring, Inc. · Oct 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · Roche Diagnostics Corp. · Aug 2003
PRECISET DAT PLUS I CALIBRATORS
K031775 · Roche Diagnostics Corp. · Aug 2003