Vaccines, Blood & Biologics
Resources for You
February 17, 2012
Calimex USA Corporation
Attention: Mr. Sam Waran
258 Hollister Avenue
Alameda, CA 94501
eOrders, Version 1
Software, Blood Bank, Stand Alone
January 27, 2012
January 27, 2012
Dear Mr. Waran:
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.
Richard J. Davey, M.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Indications for Use
eOrders, Version 1
Indications For Use:
eOrders is a web based, online ordering system for use in blood banks, laboratories and hospitals to order blood, blood-tests and related products and services. The system can be local to the blood banks, laboratories, hospitals and pharmacies or hosted in the cloud. Buyers and sellers connect securely through the internet to transact business. Options to do business by way of telephone, fax and emails are included. In this way the final status of all orders are available in real time. Orders submitted are acknowledged within agreed time period by an automated feedback process. Authorized users can check status of orders, shipments, expected delivery, fill rates and management reports online anytime, from anywhere. The system provides an electronic two-way communications on each other home pages. It also provides an online chat service for buyers and sellers to connect in real time to ask questions or seek help. Internet transmissions are secured and encrypted over SSL (secured socket layer). This allows safe and secured completion of orders remotely. Completed orders are stored in local servers or in the cloud, allowing authorized users access to them online.