(217 days)
GJS
Not Found
No
The description details a chemical and optical reaction system with kinetic analysis, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a quantitative prothrombin time testing system used for monitoring oral anticoagulation therapy, not for treating a condition.
Yes
The device is described as "intended for quantitative prothrombin time testing...for monitoring of oral anticoagulation therapy," which is a diagnostic activity used to assess a patient's condition.
No
The device description clearly states it is a "membrane-based, dry-reagent system" and uses a "meter software," indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy". This is a diagnostic test performed on a biological sample (blood) to assess a physiological state (coagulation) for the purpose of monitoring treatment.
- Device Description: The description details a system that analyzes a biological sample (blood) using reagents and optical monitoring to produce a diagnostic parameter (prothrombin time/INR).
- Sample Type: It uses "fresh, capillary whole blood," which is a biological specimen.
- Purpose: The purpose is "monitoring of oral anticoagulation therapy," which is a clinical application of diagnostic testing.
The fact that it's intended for use by trained patients or their caregivers in a home setting doesn't change its classification as an IVD. IVDs can be designed for various user types and settings.
N/A
Intended Use / Indications for Use
The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). The AvocetpT-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
Product codes
GJS
Device Description
The AvocetpT-Home is a membrane-based, dry-reagent system for use with fresh capillary whole blood. The system uses a membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value. The AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained patients or their caregivers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The AvocetpT.Home System was found to perform equivalently when used by trained lay users and healthcare professionals. Furthermore, both user populations generated results found to be equivalent to an established reference method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The AvocetpT System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).
0
Attachment F 510(k) Summary
| Introduction: | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
- Avocet Medical, Inc. 1. Submitter's name 100 Great Oaks Blvd. Suite A address, contact San Jose, CA 95119 (408) 574-7855 (phone) (408) 574-7865 (fax)
Contact person: Judith Blunt
Date prepared: April 13, 1999
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- Device name Common or Usual Name: Prothrombin Time Test
Classification Name: Prothrombin Time Test
- Device name Common or Usual Name: Prothrombin Time Test
Trade or Proprietary Name: AvocetpT-Home
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- Predicate device: The AvocetpT System: device for testing Prothrombin Time and INR in whole blood.
The Avoceter-Home is a membrane-based, dry-reagent 4. Device description: system for use with fresh capillary whole blood. The system uses a membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value. The AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.
- Predicate device: The AvocetpT System: device for testing Prothrombin Time and INR in whole blood.
1
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- Intended use: The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). The AvocetpT-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
- The Avoceter-Home is substantially equivalent in 6. Comparison to materials, design and intended use to other products predicate device that measure Prothrombin Time INR in human blood. Most notably, it is substantially equivalent to the Avocet вт. manufactured by Avocet Medical Incorporated. In fact, it is identical in materials, design and function to the Avoceter, but the labeling has been changed for physician directed, home use.
- The AvocetpT.Home System was found to perform 6. Summary of performance data equivalently when used by trained lay users and healthcare professionals. Furthermore, both user populations generated results found to be equivalent to an established reference method.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Nov 1 8 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jill Falcone Vice President of Regulatory Affairs and Quality Assurance AVOCET Medical Incorporated 100 Great Oaks Boulevard San Jose, California 95119-1347
K991286 Re: Trade Name: Avocet AcuSure System Regulatory Class: II Product Code: GJS Dated: October 22, 1999 Received: October 25, 1999
Dear Ms. Falcone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under Section 522 (a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA, are required to conduct postmarket surveillance studies. The FDA believes that under Section 522 (a) (2), discretionary postmarket surveillance will be in order for the Avocet AcuSure System. Please contact Valerie Dada at (301) 594-1293 within 15 days of receipt of this letter, to arrange a meeting to discuss the objectives and design of a future discretionary postmarket surveillance study.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment G Premarket Notification Indications for Use Statement
Device Name: AvocetpT-Home
Indications for Use:
The Avoceter-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
Peter E. Makin
(Division Sign-Off) (Division Sign-On)
Division of Clinical Laboratory Devices 510(k) Number -
Prescription ✓
000268