Cleared Traditional

ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS (K063520) - FDA 510(k) Clearance

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

K063520 · Roche Diagnostics · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 2007
Decision
87d
Days
Class 2
Risk

K063520 is an FDA 510(k) clearance for the ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS. Classified as Mycophenolic Acid Test System (product code OAV), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 16, 2007 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3840 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K063520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2006
Decision Date February 16, 2007
Days to Decision 87 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
At panel average
Panel avg: 87d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAV Mycophenolic Acid Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3840
Definition An In Vitro Diagnostic Reagent System Intended For Use In The Quantitative Determination Of Total Mycophenolic Acid In Human Serum Or Plasma As An Aid In The Management Of Mycophenolic Acid Therapy In Renal And Cardiac Transplant Patients.
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.