Cleared Abbreviated

K033306 - PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

K033306 is an FDA 510(k) clearance for PRECISET DAT PLUS II AND CFAS DAT QUALI..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with 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)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K033306

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.

DKB Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K033306.
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K033879 · Maine Standards Co. · Feb 2004
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K032574 · Dade Behring, Inc. · Oct 2003
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K031856 · Roche Diagnostics Corp. · Aug 2003
PRECISET DAT PLUS I CALIBRATORS
K031775 · Roche Diagnostics Corp. · Aug 2003