Cleared Traditional

K071474 - DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (FDA 510(k) Clearance)

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

K071474 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
561d
Days
Class 2
Risk

K071474 is an FDA 510(k) clearance for the DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CO.... Classified as Myeloperoxidase, Immunoassay, System, Test (product code NTV), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on December 10, 2008 after a review of 561 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K071474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date December 10, 2008
Days to Decision 561 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
473d slower than avg
Panel avg: 88d · This submission: 561d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTV Myeloperoxidase, Immunoassay, System, Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
Definition Myeloperoxidase, Immunoassay, System, Test Is Intended To Measure Myeloperoxidase In Human Plasma, To Be Used In Conjunction With Clinical History, Ecg And Cardiac Biomarkers To Evaluate Patients Presenting With Chest Pain That Are At Risk For Major Adverse Cardiac Events, Including Myocardial Infarction, Need For Revascularization, Or Death.
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.