System, Automated Platelet Aggregation
FDA product code JOZ · Class II (moderate risk) · 21 CFR 864.5700 · Hematology
38510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Accumetrics, Inc. 7
- Chrono-Log Corp. 6
- Helena Laboratories 4
- Aggredyne, Inc. 3
- Dade Behring, Inc. 2
- Bio/Data Corp. 2
- Centocor, Inc. 1
- Fujimori Kogyo, Co., Ltd. 1
- Coramed Technologies, LLC 1
- Verum Diagnostica GmbH 1
- Haemoscope Corp. 1
- Array Medical, Inc. 1
- Dade Intl., Inc. 1
- Bellhouse Medical, Inc. 1
- Pacific Hemostasis 1
- Volu Sol Medical Industries 1
- Hormon-Chemie Munchem Gmch 1
- General Diagnostics 1
- Dade, Baxter Travenol Diagnostics, Inc. 1
- Bay Area Hema. Onco. Clinic. & Res. L 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…JOZ · Traditional | Fujimori Kogyo, Co., Ltd. | 02/14/2020SE |
| K181777 | AggreGuide A-100 ADPJOZ · Traditional | Aggredyne, Inc. | 03/29/2019SE |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentJOZ · Special | Aggredyne, Inc. | 04/05/2017SE |
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special | Chrono-Log Corp. | 12/02/2016SE |
| K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestJOZ · Traditional | Accumetrics, Inc. | 07/24/2015SE |
| K140893 | Cora (Coagulation Resonance Analysis) System with Platelet Mapping AssayJOZ · Traditional | Coramed Technologies, LLC | 01/03/2015SE |
| K122162 | AggreguideJOZ · Traditional | Aggredyne, Inc. | 12/20/2013SE |
| K103555 | Multiplate 5.0 AggregometerJOZ · Traditional | Verum Diagnostica GmbH | 07/27/2012SE |
| K060489 | Dade PFA-100 Platelet Function Analyzer and ReagentsJOZ · Traditional | Dade Behring, Inc. | 07/21/2006SE |
| K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700JOZ · Traditional | Chrono-Log Corp. | 10/14/2005SE |
| K051231 | VERIFYNOW-P2Y12 AssayJOZ · Traditional | Accumetrics, Inc. | 08/05/2005SE |
| K042423 | Verifynow-Aspirin AssayJOZ · Special | Accumetrics, Inc. | 10/06/2004SE |
| K041502 | Thrombelastograph (Teg) Platelet Mapping AssayJOZ · Traditional | Haemoscope Corp. | 09/01/2004SE |
| K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592AJOZ · Traditional | Chrono-Log Corp. | 04/02/2004SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | Helena Laboratories | 02/14/2003SE |
| K012701 | Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)JOZ · Traditional | Accumetrics, Inc. | 06/12/2002SE |
| K013596 | Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)JOZ · Traditional | Accumetrics, Inc. | 05/16/2002SE |
| K011337 | Ultegra System Rapid Platelet Function Assay (Rpfa)JOZ · Traditional | Accumetrics, Inc. | 10/16/2001SE |
| K012723 | PlateletworksJOZ · Traditional | Helena Laboratories | 09/28/2001SE |
| K002885 | Dade PFA-100 Platelet Function Analyzer MODEL-100, Dade Pfa Collegen/Epinephrine Test…JOZ · Traditional | Dade Behring, Inc. | 06/21/2001SE |
| K992531 | Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System…JOZ · Traditional | Accumetrics, Inc. | 12/20/1999SE |
| K990398 | PlateletworksJOZ · Traditional | Array Medical, Inc. | 12/01/1999SE |
| K970505 | Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…JOZ · Traditional | Dade Intl., Inc. | 11/17/1997SE |
| K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592JOZ · Traditional | Chrono-Log Corp. | 10/22/1996SE |
| K954997 | Centocor Aggrestat, Collagen Reagent, Control ReagentJOZ · Traditional | Centocor, Inc. | 01/24/1996SE |
| K940792 | Aggro/Link VW Cofactor SoftwareJOZ · Traditional | Chrono-Log Corp. | 10/13/1994SE |
| K862302 | Blood Platelet Assay Method & ApparatusJOZ · Traditional | Bellhouse Medical, Inc. | 07/31/1986SE |
| K851669 | Monitor IV PlusJOZ · Traditional | Helena Laboratories | 07/23/1985SE |
| K800432 | Helena RistocetinJOZ · Traditional | Helena Laboratories | 03/25/1980SE |
| K800146 | Platelet Aggregation ReagentsJOZ · Traditional | Pacific Hemostasis | 02/05/1980SE |
| K791577 | Elvi 840 AggregometerJOZ · Traditional | Volu Sol Medical Industries | 09/17/1979SE |
| K790769 | Beta/PakJOZ · Traditional | Bio/Data Corp. | 05/03/1979SE |
| K781693 | Collagenreagent HormJOZ · Traditional | Hormon-Chemie Munchem Gmch | 12/07/1978SE |
| K781807 | Reagent, Firefly #395JOZ · Traditional | Chrono-Log Corp. | 11/22/1978SE |
| K780285 | Soluble CollagenJOZ · Traditional | General Diagnostics | 03/30/1978SE |
| K780047 | Platelet Aggregating ReagentsJOZ · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 03/02/1978SE |
| K770395 | Thrombo-Cetin (Ristocetin)JOZ · Traditional | Bay Area Hema. Onco. Clinic. & Res. L | 03/21/1977SE |
| K760893 | AggrecetinJOZ · Traditional | Bio/Data Corp. | 01/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0500-2026 Class III | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The…Due to an device without a premarket clearance being incorrectly package and distributed. | Accriva Diagnostics, Inc. | 10/21/2025Open, Classified |
| Z-0961-2025 Class II | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare… | Accriva Diagnostics, Inc. | 12/02/2024Open, Classified |
| Z-1121-2022 Class II | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade.…Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to… | Accriva Diagnostics, Inc. | 03/30/2022Terminated |
| Z-1639-2022 Class II | AggreGuide A-100 InstrumentThe firm identified a software design issue where the improper shut down of the instrument resulted in… | Aggredyne, Inc. | 07/23/2019Completed |
| Z-1172-2014 Class II | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test…Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous… | Accumetrics Inc | 02/13/2014Terminated |
| Z-0482-2014 Class II | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests.…Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the… | Accumetrics Inc | 11/14/2013Terminated |
| Z-1854-2012 Class II | VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a…The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically… | Accumetrics Inc | 02/06/2012Terminated |
| Z-1853-2012 Class II | VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The…The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically… | Accumetrics Inc | 02/06/2012Terminated |
| Z-0228-2007 | VerifyNow P2Y12 Assay Device Kit, Part Number 85054The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low… | Accumetrics Inc | 09/05/2006Terminated |