Cleared Traditional

CYCLOSPORINE CALIBRATOR (K011112) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 122
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K011112.
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199 · Dade Behring, Inc. · Sep 2006
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
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
K052015 · Dade Behring, Inc. · Sep 2005