510(k) · Cleared
ClearedMultiplate 5.0 Aggregometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verum Diagnostica GmbH · JOZ System, Automated Platelet Aggregation
Cleared on Jul 27, 2012 as substantially equivalent to K050265 (Chrono-Log Corp., 2005) after a 602-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Jul 27, 2012
- Review
- 602 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830749 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
- 3 generations backK962426 Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
- 2 generations backK032951 Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004
- 1 generation backK050265 Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005
- This deviceK103555 Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830749 | Platelet Aggregometer | Chrono-Log Corp. | 1983 | — |
| −3 | K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592 | Chrono-Log Corp. | 1996 | — |
| −2 | K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592A | Chrono-Log Corp. | 2004 | — |
| −1 | K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 | Chrono-Log Corp. | 2005 | — |
| 0 (this device) | K103555 | Multiplate 5.0 Aggregometer | Verum Diagnostica GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOZ device
- #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.5 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Summary page 1…telet Aggregation System The Multiplate 5.0 has been found to be substantially equivalent to the previously cleared Chrono- log Model 700 Whole Blood Lumi-Aggregometer (K050265). 1. Device Description The Multiplate® 5.0 measures platelet function in whole blood samples using electrical impedance. The M… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K050265.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JOZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOZ
Too few JOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOZ
3in 2025
MAUDE reports naming product code JOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
For use as an assayed quality control verification of the resistance measure of impedance aggregometry.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103555: Multiplate 5.0 Aggregometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103555
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026