Cleared Abbreviated

K060645 - PRECISET DAT PLUS I

K060645 is the FDA 510(k) clearance for PRECISET DAT PLUS I by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DKB) cleared through the Abbreviated 510(k) pathway after a 81-day FDA review.

K060645 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
81d
Days
Class 2
Risk

K060645 is an FDA 510(k) clearance for the PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIB.... 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 May 30, 2006 after a review of 81 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

Submission Details

510(k) Number K060645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date May 30, 2006
Days to Decision 81 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
6d faster than avg
Panel avg: 87d · This submission: 81d
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 Toxicology 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 K060645.
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · Siemens Healthcare Diagnostics · Jun 2009
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 II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · Roche Diagnostics Corp. · Dec 2003
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