Vaccines, Blood & Biologics
Resources for You
March 3, 2009
Sunquest Information Systems, Inc.
Attention: Ms. Anne Delaney
250 S. Williams Blvd.
Tucson, AZ 85711
Sunquest Blood Bank Donor 6.4
Dear Ms. Delaney:
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 has been 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.
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.
If you desire specific advice on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028. 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) 835-4709 or (301) 827-1800 or at its Internet address: http://www.fda.gov/cber/smlbus.htm.
Sheryl A. Kochman
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Indications for Use
510(k) Number: BK080042
Device Name: Sunquest Blood Bank Donor 6.4
Indications for Use:
The submission states the intended use of the Blood Bank and Blood Donor System is for use by trained health care professionals responsible for donor and transfusion services in the following ways:
- Display data that assists health care professionals to make decisions regarding the suitability of donors.
- Generate deferrals to the donor record and maintain donor records.
- Maintain phlebotomy records.
- Store records of manufactured and blood product component preparation.
- Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
- Record the release of manufactured and blood products for transfusion.
- Maintain manufactured and blood product inventory, including the tracking of autologous and directed blood products.
- Maintain a historical record of the patient’s blood bank and transfusion related data.
- Record testing results of patient specimens and blood products, either manually or through instrument interfaces.
- Maintain a product history from time received until final disposition.
- Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
- Perform quality assurance checks and maintain quality assurance records.