(26 days)
Not Found
No
The description focuses on a light-based detection of blood clotting and does not mention any AI/ML terms or processes.
No
The device is for monitoring prothrombin time as an aid in monitoring oral anti-coagulation therapy, not for treating a disease or condition.
Yes
The device is indicated for the "quantitative determination of prothrombin time (PT)... as an aid in monitoring oral anti-coagulation therapy," which is a diagnostic purpose to assess a patient's coagulation status.
No
The device description explicitly states the system consists of a "meter and test strip," which are hardware components. The software is part of the meter's functionality, but the device as a whole is not software-only.
Yes, the Harmony INR Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of prothrombin time (PT) in capillary whole blood... as an aid in monitoring oral anti-coagulation therapy." This involves testing a sample taken from the human body (blood) in vitro (outside the body) to provide information about a physiological state (blood clotting ability).
- Device Description: The description details how the device interacts with a blood sample using reagents and light to measure a biological process (blood clotting). This is characteristic of an in vitro diagnostic test.
The definition of an IVD device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The Harmony system fits this description by providing information used to monitor and manage a medical condition (oral anti-coagulation therapy).
N/A
Intended Use / Indications for Use
For the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.
Product codes
GJS
Device Description
The Harmony System consists of a meter and test strip. When a drop of blood is placed on the test strip, the blood is drawn into the reaction cells and mixed with reagents that cause blood clotting to begin. The meter monitors the blood clotting process by passing a light beam through the blood sample being tested. The meter detects blood clot formation and, at the conclusion of the test, the prothrombin time is displayed in International Normalized Ratio (INR) units.
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
properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals
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 study conducted to compare equivalency of the Rubicon 510(k) cleared device to the modified Harmony System met the performance requirements for accuracy and precision relative to the reference laboratory system. Equivalent performance in meeting user requirements was determined.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Convenience. Confidence. Control.
Johnson+Johnson company
SEP 3 0 2002
510(k) Summary
LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
Tel 408 263.9789 Fax 408 946.6070 www.LifeScan.com
| Submitted By: | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
(408) 942-5903
(408) 942-5606 (fax) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | John E. Hughes |
| Date of Preparation: | September 3, 2002 |
| Establishment Registration
No: | 2939301 |
| Device Name: | Harmony™ INR Monitoring System |
| Common/Classification
Name: | Prothrombin Time Test |
| Device Classification: | Class II |
| Regulation Number: | CFR 864.7750 |
| Classification Panel: | Hematology |
| Product Code: | GJS |
| Predicate Device: | Rubicon™ Prothrombin Time Monitoring System
K001699 |
Device Description:
The Harmony System consists of a meter and test strip. When a drop of blood is placed on the test strip, the blood is drawn into the reaction cells and mixed with reagents that cause blood clotting to begin. The meter monitors the blood clotting process by passing a light beam through the blood sample being tested. The meter detects blood clot formation and, at the conclusion of the test, the prothrombin time is displayed in International Normalized Ratio (INR) units.
Intended Use:
For the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.
LifeScan, Inc. Harmony ™ INR Monitoring System 510(k) Summary
1
Comparison to Predicate Device:
The Harmony INR Monitoring System and the Rubicon Prothrombin Time Monitoring System both consist of a meter and disposable test strip. Both systems employ whole blood as a test sample and can be used by laypersons in the home environment to monitor oral anti-coagulation therapy. Both employ thromboplastin to cause blood coagulation.
The systems differ in that the Harmony System has been enhanced by reducing the number of calibration codes required which makes the product simpler to use. In addition, an active use confirmation was added to ensure the integrity of the LCD display prior to each use.
Environmental and Non-Clinical Testing:
Applicable environmental and non-clinical testing was performed per IEC 60601 and other applicable standards and procedures. The Harmony INR Monitoring System passed all tests.
Performance Testing:
The study conducted to compare equivalency of the Rubicon 510(k) cleared device to the modified Harmony System met the performance requirements for accuracy and precision relative to the reference laboratory system. Equivalent performance in meeting user requirements was determined.
Conclusion:
The test results demonstrate the Harmony INR Monitoring System is substantially equivalent to the Rubicon Prothrombin Time Monitoring System.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
SEP 3 0 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. John E. Hughes Senior Manager, Regulatory Submissions LifeScan. Inc. 1000 Gibraltar Drive Milpitas, California 95035
Re: K022922
Trade/Device Name: Harmony™ INR Monitoring System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: September 3, 2002 Received: September 4, 2002
Dear Mr. Hughes:
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. 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 (PMA), 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/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
510(k) Number:
Name:
Harmony™ INR Monitoring System
Indications for Use:
The Harmony INR Monitoring System is indicated for the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
Josephine Bautcher
(Division Sign-Off) (Division of Clinical Laboratory Devices 222922