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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

BK100037 Letter

BBK Technology LLC
Attention: Ms. Catherine Averkamp
2910 E. Highland Ave.
Phoenix, AZ  85016

Re:
Trade/Device Name:
Product Name:
Regulatory Class:
Product Code:
Dated:
Date Received: 
BK100037
RC-AID, version 2.0
Software, Blood Bank, Stand Alone
Unclassified
MMH
August 23, 2010
August 26, 2010

Dear Ms. Averkamp:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance.  Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).  For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

/signature/

Richard J. Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure


Indications for Use

510(k) Number: BK100037
Device Name: RC-AID, version 2.0
Indications For Use:

RC-AID is an electronic aid to trained blood transfusion service technologists for use in the identification and ruling out of antibodies to human red blood cell antigens from antibody test systems.  RC-AID is updated with the red cells in the inventory and it assists technologists in quickly choosing the best cells to complete the identification.  RC-AID searches the cells in the inventory for specific cells that have the antigens that will complete the identification.

RC-AID duplicates the logic used in existing antibody test systems in an electronic version of the custom panel created by the technologist.  If an antigen is present on the cell and the specimen did not react, the presence of the corresponding antibody is tentatively excluded.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448