February 27, 1998
Mr. Richard Kriozere
1550 Barclay Blvd.
Buffalo Grove, IL 60089
|Product:||DONOR-ID, version 1.0|
Dear Mr. Kriozere:
We have reviewed your Section 510(K) notification of intent to market the device referenced above and have determined that the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act that include requirements for registration, listing of devices, good manufacturing practice, labeling and prohibitions against misbranding and adulteration.
Although your device has been determined to be "substantially equivalent", there are deficiencies in documentation that should be addressed before submitting a future premarket notification for this or a similar device. We are including suggestions for improvement for your consideration as you modify or upgrade this software package or design additional software. For further guidance, please refer to "Reviewer Guidance for a Premarket Notification submission for Blood Establishment Computer Software, January 13, 1997".
Our suggestions for future submissions is as follows:
When responding to a letter requesting additional infpormation, do not submit a completely revised 510(k), as such a submission necessitates a complete review. Please submit only the response to the stated question, referencing where the supporting information can be found in the submitted material.
Your design plan for accommodating the year 2000 describes only a change to the birth year field. Please note that all date fields, e.g., donation date, etc., will require a change in design.
The device master record and the device history record should be maintained as two separate records in accordance with 21 CFR 820.181 and 820.184 respectively. Your SOP 0403, "Device Master History Record" should be revised accordingly.
If your device has been classified into either class II (Special Controls) or class III (Premarket Approval), (see above), it may be subject to the above and additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note that this response to your Premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or regulations.
This letter will allow you to begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff at (301) 827-3028.
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research