Vaccines, Blood & Biologics
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Calimex USA Corporation
Attention: Mr. Sam Waran
258 Hollister Avenue
Alameda, CA 94501
Date Received: September 25, 2009
Device Code: MMH
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 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, ²Misbranding by reference to premarket notification² (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.
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: BK090054
Device Name: Picture-ID
Indications For Use:
Picture-ID is a new biometrics, web services-based, blood donor identity verification software that incorporates donor self-administered health history questionnaire. It positively verifies donor identity using Fingerprint, date of birth and gender and then matches the identified donor to their picture on file. Options to use State or Donor ID is included. Positively identified donors are checked for visit eligibility. Visit-eligible donors are allowed to edit their demographic data and are presented with an FDA recognized, AABB Uniform electric Donor History Questionnaire (eDHQ) in pdf form for completion online. Picture-ID supports multi-lingual text display. Electronic signatures enable a paperless workflow process. The eDHQ can be completed on site or remotely through the internet. Internet transmissions are secured and encrypted over SSL (secured socket layer). Completed eDHQs are stored on local blood bank servers allowing donors to pre-complete DHQs remotely on the day of donation, come to the blood or mobile center, positively identify themselves by our three factor authentication, then review, sign and submit the eDHQ online. The completed and donor-signed eDHQ is used by qualified and trained blood bank staff, according to their SOPs, to interview the donor in a secured confidential area, review the answers, take vitals and determine donation eligibility.
The eDHQ is configurable. Configured or changed eDHQ is approved, version-controlled, converted to PDF form and placed online in accordance to the blood bank’s standard operating procedures. Write access to sections of the eDHQ are selectively controlled and managed.