Cleared Traditional

K011112 - CYCLOSPORINE CALIBRATOR

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

K011112 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K011112

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.

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 Chemistry 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 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