(150 days)
The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma.
Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.
Not Found
The provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. This document is a 510(k) premarket notification letter from the FDA to DiaPharma Group, Inc. for their DiaPharma Factor X Kit. It primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance requirements.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study demonstrating compliance. This type of detailed performance data is typically found in a clinical study report or a more extensive technical file, not in the FDA's initial 510(k) clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer J. Kiblinger Technical & Regulatory Affairs Manager DiaPharma Group, Inc. 8948 Beckett Road West Chester, Ohio 45069
JUL 1 2 2004
K040362 Re:
Trade/Device Name: DiaPharma Factor X Kit Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: June 14, 2004 Received: June 15, 2004
Dear Ms. Kiblinger:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert Z. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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6/14/2004 Submission of Requested Additional Information 510(k) Number K040362
DiaPharma Group, Inc. DiaPharma Factor X (FX) Kit Premarket Notification
STATEMENT OF INTENDED USE
510(K) Number (if known): K040362
Device Name: DiaPharma Factor X Kit
Intended Use:
The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma.
Indications for Use:
Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Division Sign-Off | |
|---|---|
| ------------------- | -- |
| Over-the-Counter Use | _________________ |
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Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).