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Vaccines, Blood & Biologics

BK120035 Letter


Calimex USA Corporation
Attention: Mr. Sam Waran
258 Hollister Avenue
Alameda, CA 94501
Re:                                         BK120035
Device Name:                                     Picture - ID Version 2.0
Regulation Name:                  Stand Alone, Blood Bank Software
Regulatory Class:                   Unclassified
Product Code:                         MMH
Dated:                                     December 5, 2012
Received:                               December 5, 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 ( the 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 (21 CFR 803), please go to: 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:
Sincerely yours,
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:          BK120035
Device Name:            Picture – ID Version 2.0
Indications for Use:
Indications for use of Picture-ID v 2.0 is a modular, standalone, computer assisted, online donor interview, phlebotomy, and workflow-based donor management system that incorporates optional biometric identity verification at any stage in the process. It can positively verify donor identity using fingerprint, date of birth and gender and then match the identified donor to their picture on file. Options to use State ID or Donor ID is included. Positively identified donors may be checked for visit eligibility. Donors can edit their demographic data and be presented with an FDA recognized, AABB Uniform electronic Donor History Questionnaire (eDHQ) or similar forms approved by the blood center for completion online.  The eDHQ is configurable. Configured or changed eDHQ is approved, version-controlled converted to web-form and placed online in accordance to the blood bank’s SOPs.  Write access to sections of the eDHQ are selectively controlled and managed.  Picture-ID supports multi-lingual text and voice. 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 in local blood bank database servers, as well as in encrypted barcode, allowing donors to pre-complete DHQs remotely on 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.  The barcode can be printed by the donor or carried digitally in a handheld device, unencrypted and eDHQ re-created at site as needed. 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. Donation eligibility is based on complete eDHQ or on an exception of unexpected answers. Picture-ID does not make the final donation decision. 
Outputs are provided from the system in files and reports. Output files can be formatted to the requirement of third party blood establishment software for upload to their system. Third party applications can apply their checks, balances and controls before importing them to their system.

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