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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK080044 Letter

June 10, 2009

Healthcare-ID
Attention: Mr. Frank Sadorf
1635 Barclay Blvd.
Buffalo Grove, IL 60089

Re:                  BK080044
Product:           Donor-ID Web™, version 3.1.4
Date Received:  29-AUG-08
Classification:    Unclassified
Device Code:     MMH 

Dear Mr. Sadorf:

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.

Sincerely yours,

 

Sheryl A. Kochman
Acting Director 
Division of Blood Applications 
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure


Indications for Use                                       

 

510(k) Number: BK080044                                                

Device Name:  Donor-ID Web™, version 3.1.4                   

Indications For Use:

Indications for use of Donor-ID Web™ are the need to reduce or eliminate errors and omissions in the blood donation process.

Donor-ID Web™ is a computer system to be used by trained blood center staff to manage donors throughout the blood donation process and to collect and record data.  Through the use of computers communicating in real time to the system as it runs on a server, the data obtained for input include:  donor demographic data;  responses to health history questions (direct oral questioning with optional CASI) and follow up documentation;  physical exam results;  the phlebotomy data;  and donor signature.  Optical Computer Assisted Self Interview (CASI) provides the donor with the opportunity to respond to health history questions 1) at the collection site; or 2) from an external computer accessing the blood center’s controlled and secure intranet resulting in a printed document with bar codes that is used upon presentation by the specific donor at the collection site to input the data provided by the donor and to confirm the date.  All donor responses through CASI are reviewed by a blood center employee.

During the phlebotomy phase, staff members may use wireless hand held computers to collect data and to communicate in real time to the system as it runs on a server.  Donor-ID Web™ requires that all required qualifying data be entered and that it be within bounds established by the blood center. Donor-ID Web™ minimizes the need for character data entry by using selection from lists created by the blood center and bar cod scanning.