Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5700](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5700) → JOZ — System, Automated Platelet Aggregation # JOZ · System, Automated Platelet Aggregation _Hematology · 21 CFR 864.5700 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ ## Overview - **Product Code:** JOZ - **Device Name:** System, Automated Platelet Aggregation - **Regulation:** [21 CFR 864.5700](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5700) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 38) Showing 20 most recent of 38 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K191364](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K191364.md) | 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 | Fujimori Kogyo, Co., Ltd. | Feb 14, 2020 | SESE | | [K181777](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K181777.md) | AggreGuide A-100 ADP | Aggredyne, Inc. | Mar 29, 2019 | SESE | | [K163274](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K163274.md) | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | Apr 5, 2017 | SESE | | [K161329](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K161329.md) | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | Chrono-Log Corp. | Dec 2, 2016 | SESE | | [K141427](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K141427.md) | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | Accumetrics, Inc. | Jul 24, 2015 | SESE | | [K140893](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K140893.md) | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY | Coramed Technologies, LLC | Jan 3, 2015 | SESE | | [K122162](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K122162.md) | AGGREGUIDE | Aggredyne, Inc. | Dec 20, 2013 | SESE | | [K103555](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K103555.md) | MULTIPLATE 5.0 AGGREGOMETER | Verum Diagnostica GmbH | Jul 27, 2012 | SESE | | [K060489](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K060489.md) | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | Dade Behring, Inc. | Jul 21, 2006 | SESE | | [K050265](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K050265.md) | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Chrono-Log Corp. | Oct 14, 2005 | SESE | | [K051231](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K051231.md) | VERIFYNOW-P2Y12 ASSAY | Accumetrics, Inc. | Aug 5, 2005 | SESE | | [K042423](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K042423.md) | VERIFYNOW-ASPIRIN ASSAY | Accumetrics, Inc. | Oct 6, 2004 | SESE | | [K041502](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K041502.md) | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Haemoscope Corp. | Sep 1, 2004 | SESE | | [K032951](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K032951.md) | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Chrono-Log Corp. | Apr 2, 2004 | SESE | | [K023761](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K023761.md) | PLATELETWORKS, MODELS PW-A, PW-C | Helena Laboratories | Feb 14, 2003 | SESE | | [K012701](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K012701.md) | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | Accumetrics, Inc. | Jun 12, 2002 | SESE | | [K013596](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K013596.md) | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | Accumetrics, Inc. | May 16, 2002 | SESE | | [K011337](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K011337.md) | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | Accumetrics, Inc. | Oct 16, 2001 | SESE | | [K012723](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K012723.md) | PLATELETWORKS | Helena Laboratories | Sep 28, 2001 | SESE | | [K002885](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K002885.md) | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP | Dade Behring, Inc. | Jun 21, 2001 | SESE | ## Top Applicants - Accumetrics, Inc. — 7 clearances - Chrono-Log Corp. — 6 clearances - Helena Laboratories — 4 clearances - Aggredyne, Inc. — 3 clearances - Bio/Data Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com