(268 days)
Not Found
No
The device description and performance studies focus on a direct measurement of pressure changes and calculation of AUC, with a fixed cutoff for interpretation. There is no mention of adaptive algorithms, learning from data, or complex pattern recognition that would indicate AI/ML.
No.
This device is an in vitro diagnostic device used to analyze primary hemostatic function, not to treat a condition.
Yes
The "Device Description" explicitly states, "The T-TAS 01 system is an in vitro diagnostic device." Additionally, the "Intended Use / Indications for Use" section describes its use for analyzing "the platelet thrombus formation process (primary hemostatic function)" and mentions that "AUC
No
The device description explicitly states it is comprised of a "tabletop instrument controlled by a dedicated PC and a disposable, single-use flow chamber," indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "The T-TAS 01 system is an in vitro diagnostic device..."
- Intended Use: The "Intended Use / Indications for Use" section describes the device's purpose as being used "in the clinical laboratory" for the "analysis of the platelet thrombus formation process (primary hemostatic function)" using "whole blood specimens." This clearly indicates it's used to test samples taken from the human body to provide information about a patient's health status.
- Mechanism: The "Device Description" details how the device analyzes blood samples to measure platelet function, which is a diagnostic process performed outside of the body.
N/A
Intended Use / Indications for Use
The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory.
The T-TAS 01 PL chip is intended for use in the clinical laboratory for the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPA-anticoagulated whole blood specimens to measure platelet adhesion to a thrombogenic collagen-coated surface and aggregation, which causes an increase in flow pressure inside the PL chip. The test measures primary hemostatic function as the area under the pressure-time curve (AUC), with AUC
§ 864.5700 Automated platelet aggregation system.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2020
Fujimori Kogyo Co., Ltd. Jeffrey Dahlen Project Leader 11435 Merritage Court San Diego, California 92131
Re: K191364
Trade/Device Name: T-TAS 01 System with PL Chip Regulation Number: 21 CFR 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: Class II Product Code: JOZ Dated: May 20, 2019 Received: May 22, 2019
Dear Jeffrey Dahlen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name T-TAS 01 System with PL chip
Indications for Use (Describe)
The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory.
The T-TAS 01 PL chip is intended for use in the clinical laboratory for the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPA-anticoagulated whole blood specimens to measure platelet adhesion to a thrombogenic collagen-coated surface and aggregation, which causes an increase in flow pressure inside the PL chip. The test measures primary hemostatic function as the area under the pressure-time curve (AUC), with AUC Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary [as required by 21 CFR 807.92(c)]
Submitter information:
| Company Name: | Fujimori Kogyo Co., Ltd. (ZACROS) |
|---|---|
| Company Address: | Shinjuku First West Building |
| 1-23-7 Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023 | |
| JAPAN | |
| Company Phone: | +81-3-6381-2573 |
| Company Fax: | +81-3-5909-5779 |
| Contact Name: | Jeffrey Dahlen, Ph.D. |
| Contact Email: | jeff-dahlen@zacros.co.jp |
| Date Summary was Prepared: | 2020-02-14 |
| Product information: | |
| 510(k) Number | K191364 |
| Trade/Proprietary Name(s): | Total Thrombus-formation Analysis (T-TAS) 01 System, which consists of: |
| T-TAS 01 Instrument (Catalog #18001) PL chip for T-TAS 01 (Catalog #18002) PL chip Reservoir Set for T-TAS 01 (Catalog #18003) BAPA tube for T-TAS 01 (Catalog #18004) | |
| Common/Usual Name(s): | Automated Platelet Aggregation System |
| Product Code: | JOZ |
| Regulation: | 21 CFR 864.5700 |
| Regulatory Classification: | Class II |
| Panel: | Hematology |
Predicate Method:
| Product Name: | Dade Behring (now Siemens) PFA-100 |
|---|---|
| 510(k) Document Number: | K060489 |
Device Description:
The T-TAS 01 system is an in vitro diagnostic device that is comprised of tabletop instrument controlled by a dedicated PC and a disposable, single-use flow chamber. The PL Chip for T-TAS 01 is designed to specifically measure platelet thrombus formation (PTF) under physiological conditions on a collagen-coated analytical path consisting of 26 microcapillary channels. Platelet thrombus formation is a direct indicator of the patient's primary hemostatic function. The assay is performed under arterial flow conditions using benzylsulfonyl-D-Arg-Pro-4-amidinobenzylamide (BAPA)-anticoagulated whole blood samples. BAPA is an anticoagulant that inhibits thrombin and factor Xa, blocking the coagulation cascade and allowing the PL assay to specifically measure only the platelet thrombus formation process (primary hemostasis). During the assay, the blood sample is exposed to arterial shear stresses at 1,500 s 4 in the presence of a collagencoated surface, which causes platelet attachment to collagen mediated by von Willebrand factor (vWF), and platelet activation. Platelet activation causes the release of endogenous factors contained within the platelets that recruit and activate other platelets and cause aggregation, and platelet thrombus formation. The growing platelet thrombus causes occlusion of the microcapillary channels, which increases the flow pressure within the assay chip. The process of platelet thrombus formation in the flow chamber is continuously monitored by a pressure sensor that tracks pressure changes in the flow path. Results are
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calculated automatically within 10 minutes or when the pressure a reading reaches 60 kPa above the baseline pressure, whichever occurs first. Results are displayed as AUC, which is the flow pressure curve over 10 minutes.
AUC results less than 260 are associated with abnormal primary hemostatic function.
Intended Use/Indications for Use:
The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory.
The T-TAS 01 PL chip is intended for use in the clinical laboratory for the analysis of the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPAanticoagulated whole blood specimens to measure platelet adhesion to a thrombogenic collagen-coated surface and aggregation, which causes an increase in flow pressure inside the PL chip. The test measures primary hemostatic function as the area under the pressure-time curve (AUC), with AUC 170 seconds | AUC