May 25, 2012
Rowny Systems, Inc.
Attention: Mr. Peter Rowny
7555 Spring Lake Drive
Bethesda, MD 20817-6507
|Antigen Plus Version 7.4|
Software, Blood Bank, Stand Alone
April 13, 2012
April 24, 2012
Dear Mr. Rowny:
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 807); labeling (21 CFR 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 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 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" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR 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.
Richard J. Davey, M.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications for Use
510(k) Number: BK110045
Device Name: Antigen Plus Version 7.4
Indications For Use:
Antigen Plus 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, it is updated with each cell donor number and lot number, and it assists the technologist in selecting cells to complete the identification of antibodies.
Antigen Plus duplicates the logic used in existing antibody test systems in an electronic version of the printed panel for each lot of reagent cells: if an antigen is present on the cell and the specimen did not react, the presence of the corresponding antibody is tentatively ruled out.
Antigen Plus is used to search a laboratory’s inventory of reagent or patient red blood cell samples for any pattern of positive or negative antigens that will best help complete antibody identification.