Cleared Traditional

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) (K102772) - FDA 510(k) Clearance

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

K102772 · Siemens Heatlhcare Diagnostics, Inc. · Chemistry device
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Oct 2011
Decision
378d
Days
Class 2
Risk

K102772 is an FDA 510(k) clearance for the DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHEN.... Classified as Mycophenolic Acid Test System (product code OAV), Class II - Special Controls.

Submitted by Siemens Heatlhcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on October 7, 2011 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3840 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K102772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date October 07, 2011
Days to Decision 378 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 88d · This submission: 378d
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 Chemistry devices follow this clearance model.