Cleared Traditional

K052015 - DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108

K052015 is an FDA 510(k) clearance for DIMENSION EXTENDED RANGE CYCLOSPORINE C..., manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K052015 · Dade Behring, Inc. · Toxicology device
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Sep 2005
Decision
48d
Days
Class 2
Risk

K052015 is an FDA 510(k) clearance for the DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 12, 2005 after a review of 48 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

FDA 510(k) Submission Details - K052015

510(k) Number K052015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date September 12, 2005
Days to Decision 48 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
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K052015.
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503 · Dade Behring, Inc. · Jun 2006
DIMENSION TACR CALIBRATOR, MODEL DC107
K060503 · Dade Behring, Inc. · May 2006
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108 · Dade Behring, Inc. · Feb 2006
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · Roche Diagnostics Corp. · Dec 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · Roche Diagnostics Corp. · Oct 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp. · Feb 2003