Cleared Traditional

MULTIPLATE 5.0 AGGREGOMETER (K103555) - FDA 510(k) Clearance

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

K103555 · Verum Diagnostica GmbH · Hematology device
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Jul 2012
Decision
602d
Days
Class 2
Risk

K103555 is an FDA 510(k) clearance for the MULTIPLATE 5.0 AGGREGOMETER. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Verum Diagnostica GmbH (Munich, DE). The FDA issued a Cleared decision on July 27, 2012 after a review of 602 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology 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: 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 Hematology submissions.

View all Verum Diagnostica GmbH devices

Submission Details

510(k) Number K103555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2010
Decision Date July 27, 2012
Days to Decision 602 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
489d slower than avg
Panel avg: 113d · This submission: 602d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 Hematology devices follow this clearance model.