Cleared Traditional

K053061 - EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

K053061 is an FDA 510(k) clearance for EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY, manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code MKW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K053061 · Dade Behring, Inc. · Toxicology device
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Feb 2006
Decision
98d
Days
Class 2
Risk

K053061 is an FDA 510(k) clearance for the EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY. Classified as Cyclosporine (product code MKW), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 6, 2006 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1235 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

FDA 510(k) Submission Details - K053061

510(k) Number K053061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2005
Decision Date February 06, 2006
Days to Decision 98 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
11d slower than avg
Panel avg: 87d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MKW Device Classification - Class 2, Special Controls

Product Code MKW Cyclosporine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1235
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 - MKW Cyclosporine

Devices cleared under the same product code (MKW) and FDA review panel - the closest regulatory comparables to K053061.
ARCHITECT CYCLOSPORINE
K080751 · Fujirebio Diagnostics,Inc. · Sep 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236 · Dade Behring, Inc. · Aug 2006
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K052017 · Dade Behring, Inc. · Sep 2005
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · Microgenics Corp. · Oct 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · Dade Behring, Inc. · Oct 2002