(71 days)
Not Found
No
The device description details a chemical and electrical reaction to measure prothrombin time, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for monitoring blood coagulation, not for treating any condition. Its purpose is diagnostic/monitoring, not therapeutic.
Yes
Explanation: The device is used for "quantitative prothrombin time testing" to monitor patients on oral anticoagulant therapy. This monitoring provides information about a patient's physiological state to help manage their treatment, which falls under the definition of a diagnostic device.
No
The device description explicitly mentions "test strips and meter" which are hardware components used to measure capillary blood PT levels. The software likely processes the data from these hardware components, but the device itself is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for "quantitative prothrombin time testing of fresh, capillary whole blood." This involves testing a sample taken from the body (in vitro) to provide diagnostic information about the patient's coagulation status.
- Device Description: The description details how the device analyzes a blood sample using reagents on a test strip to measure the time it takes for a clot to form. This is a classic example of an in vitro diagnostic test.
- Monitoring of Oral Anticoagulant Therapy: The purpose of the test is to monitor patients on oral anticoagulant therapy, which is a diagnostic and management function.
The fact that it tests a sample outside of the body to provide diagnostic information about a medical condition (coagulation status) firmly places it in the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AcuSure System for Patient Self-Testing is intended for the quantitative prothombin time testing of fresh, capillary whole blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician. The AcuSure System for Patient Self-Testing is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.
The AcuSure Pro System for Professional Use is intended for the quantitative prothrombin time testing of fresh, capillary whole blood by healthcare professionals. The AcuSure Pro System is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The AcuSure and AcuSure Pro test strips and meter measure capillary blood PT levels. When the sample is applied to the target area on the test strip, the meter detects the electrical drop between two electrodes on the test strip and begins the test. Inside the membrane of the test strip the red blood cells are separated from the plasma. The membrane also contains the reagents necessary to cause the coagulation reaction (clot formation) to occur. The thrombin, formed as part of the coagulation reaction, reacts with a reagent, which causes a fluorescent molecule to be released. The time from the initial resistance drop to the onset of fluorescence is proportional to the prothrombin time of the sample.
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
Selected and suitably trained patients or their caregivers on the prescription of the treating physician (for Patient Self-Testing).
Healthcare professionals (for Professional Use).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K99400b". The characters are written in a cursive style with varying stroke thicknesses.
Avocet Medical, Inc. Premarket Notification, 510(k), for the Avocet AcuSure System (for Patient Self-Testing) and the AcuSure Pro System (for Professional Use)
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. |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name,
address, contact,
date prepared | Avocet Medical, Inc.
100 Great Oaks Blvd.
San Jose, CA 95119
(408)-574-6638
Contact person: Jill Falcone
Date Prepared: November 22, 1999 |
| Device Name | Proprietary Name: Avocet AcuSure System (for Patient Self-
Testing) and the Avocet AcuSure Pro System (for Professional
Use)
Common Name: Prothrombin Time Test |
| Predicate Device | The AcuSure System (for patient self-testing) and the AcuSure Pro
System (for professional use) are exactly the same device except
that the AcuSure System (for patient self-testing) has labeling and
quality control recommendations for the home user whereas the
AcuSure Pro System has labeling and quality control
recommendations for the professional user. The quality control
and performance characteristics sections of the labeling for the
AcuSure Pro System contain the same language that was
previously cleared for professional use in 510(k)# K980839. |
| Device Description | The AcuSure and AcuSure Pro test strips and meter measure
capillary blood PT levels. When the sample is applied to the target
area on the test strip, the meter detects the electrical drop between
two electrodes on the test strip and begins the test. Inside the
membrane of the test strip the red blood cells are separated from
the plasma. The membrane also contains the reagents necessary to
cause the coagulation reaction (clot formation) to occur. The
thrombin, formed as part of the coagulation reaction, reacts with a
reagent, which causes a fluorescent molecule to be released The |
1
time from the initial resistance drop to the onset of fluorescence is proportional to the prothrombin time of the sample. Intended Use The AcuSure System for Patient Self-Testing is intended for the quantitative prothombin time testing of fresh, capillary whole blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician. The AcuSure System for Patient Self-Testing is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes. The AcuSure Pro System for Professional Use is intended for the quantitative prothrombin time testing of fresh, capillary whole blood by healthcare professionals. The AcuSure Pro System is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes. Comparison to Predicate Device The AcuSure System (for patient self-testing) and the AcuSure Pro System (for professional use) are substantially equivalent. The AcuSure System (for patient self-testing) and the AcuSure Pro System (for professional use) are exactly the same device except that the AcuSure System (for patient self-testing) has labeling and quality control recommendations for the home user whereas the AcuSure Pro System has labeling and quality control recommendations for the professional user. The quality control and performance characteristics sections of the labeling for the AcuSure Pro System contain the same language that was previously cleared for professional use in 510(k)# K980839.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Ms. Jill Falcone Vice President of Regulatory Affairs and Quality Assurance Avocet Medical Incorporated 100 Great Oaks Boulevard San Jose, California 95119-1347
3 2000 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K994006
Trade Name: Avocet AcuSure System (for Patient Self-Testing) and the Avocet AcuSure Pro System (for Professional Use)
Regulatory Class: II Product Code: GJS Dated: November 11, 1999 Received: November 24, 1999
Dear Ms. Falcone:
We have reviewed your Section 510(k) notification of intent to market the Avocet AcuSure System (for Patient Self-Testing) and the Avocet AcuSure Pro System (for Professional Use) devices under a single 510(k) number as referenced above and we have determined that these two devices are 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). Please note that the consolidation of these two devices under a single 510(k) number, K994006, does not change the fact that there are two separate and different intended uses for these devices, one for professional use and one for home use by prescription, and two different sets of quality control recommendations for the two devices. 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
3
Page 2
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 9940000
Device Names: Avocet AcuSure System for Patient Self-Testing and Avocet AcuSure Pro System for Professional Use.
Indications For Use:
The AcuSure System for Patient Self-Testing is intended for the quantitative prothombin time testing of fresh, capillary whole blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician. The AcuSure System for Patient Self-Testing is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.
The AcuSure Pro System for Professional Use is intended for the quantitative prothrombin time testing of fresh, capillary whole blood by healthcare professionals. The AcuSure Pro System is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K994006 |
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
Over-
(Option
(Optional Format 1-2-96)