Cleared Traditional

K103555 - MULTIPLATE 5.0 AGGREGOMETER

K103555 is the FDA 510(k) clearance for MULTIPLATE 5.0 AGGREGOMETER by Verum Diagnostica GmbH. It is a Class 2 Hematology device (product code JOZ) cleared through the Traditional 510(k) pathway after a 602-day FDA review.

K103555 · Verum Diagnostica GmbH · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - JOZ System, Automated Platelet Aggregation

All 13
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K103555.
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
K191364 · Fujimori Kogyo, Co., Ltd. · Feb 2020
AggreGuide A-100 ADP
K181777 · Aggredyne, Inc. · Mar 2019
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · Dade Behring, Inc. · Jul 2006
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · Helena Laboratories · Feb 2003
PLATELETWORKS
K012723 · Helena Laboratories · Sep 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885 · Dade Behring, Inc. · Jun 2001