Cleared Traditional

K032574 - DIMENSION DRUG CALIBRATOR II

K032574 is the FDA 510(k) clearance for DIMENSION DRUG CALIBRATOR II by Dade Behring, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K032574 · Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
47d
Days
Class 2
Risk

K032574 is an FDA 510(k) clearance for the DIMENSION DRUG CALIBRATOR II, MODEL DC49C. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on October 6, 2003 after a review of 47 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K032574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2003
Decision Date October 06, 2003
Days to Decision 47 days
Submission Type Traditional
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
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 75
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K032574.
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K060645 · Roche Diagnostics Corp. · May 2006
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K051088 · Lin-Zhi International, Inc. · Jun 2005
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · Roche Diagnostics Corp. · Dec 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
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318 · Randox Laboratories, Ltd. · Sep 2001