Cleared Traditional

K011112 - CYCLOSPORINE CALIBRATOR

K011112 is the FDA 510(k) clearance for CYCLOSPORINE CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K011112 · Dade Behring, Inc. · Chemistry device
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Jul 2001
Decision
97d
Days
Class 2
Risk

K011112 is an FDA 510(k) clearance for the CYCLOSPORINE CALIBRATOR. 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 July 17, 2001 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K011112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2001
Decision Date July 17, 2001
Days to Decision 97 days
Submission Type Traditional
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
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 91
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K011112.
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · Dade Behring, Inc. · May 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · Lin-Zhi International, Inc. · Apr 2002
DRI ECSTASY URINE CALIBRATORS
K012109 · Microgenics Corp. · Aug 2001
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473 · Beckman Coulter, Inc. · Nov 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
K993022 · Beckman Coulter, Inc. · Nov 1999
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555 · Roche Diagnostic Systems, Inc. · Dec 1998