Cleared Traditional

ARCHITECT CYCLOSPORINE (K080751) - FDA 510(k) Clearance

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

K080751 · Fujirebio Diagnostics,Inc. · Toxicology device
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Sep 2008
Decision
177d
Days
Class 2
Risk

K080751 is an FDA 510(k) clearance for the ARCHITECT CYCLOSPORINE. Classified as Cyclosporine (product code MKW), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 11, 2008 after a review of 177 days - an extended review cycle.

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 Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K080751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date September 11, 2008
Days to Decision 177 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 87d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 8
Devices cleared under the same product code (MKW) and FDA review panel - the closest regulatory comparables to K080751.
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236 · Dade Behring, Inc. · Aug 2006
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
K053061 · Dade Behring, Inc. · Feb 2006
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K052017 · Dade Behring, Inc. · Sep 2005
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · Dade Behring, Inc. · Oct 2002