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Donor-ID version 3.2.6 receives 510k clearance from FDA

Buffalo Grove, IL, February 9, 2015 – Healthcare-ID, Inc. announces that the FDA has cleared their 510k submission for Donor-IDä software version 3.2.6.


“We are very happy to have received clearance on version 3.2.6.  As a company, we put a lot of effort on compliance with FDA guidelines and it is rewarding to receive the clearance letter from the FDA.  This was our first full submission of Donor-ID in several years and we are happy that it went smoothly,” states Steve Sadorf, Vice President of Quality, Human Resource, and Finance at Healthcare-ID.


History of FDA clearance:

Ø  February 1998:  Donor-ID 1.0; initial clearance

Ø  March 2000:  Donor-ID 2.0; cumulative changes

Ø  April 2002:  Donor-ID 2.2; cumulative changes

Ø  October 2003:  Donor-ID 2.5; addition of the CASI module to the donor screening software that already included modules for Registration, Health History, Physical Exam, and Phlebotomy

Ø  February 2007:  Donor-ID 3.0; upgrade to a web-based application also offered enhanced capabilities like wireless PDA for Phlebotomy, network printing, and customer-configurable web pages and reports

Ø  June 2009:  Donor-ID Web™, version 3.1.4; included the iCASI module, providing the option for donors to answer health history questions over the internet prior to arrival at the collection site. It also included donor electronic signature capture and a donor Self Check In module

Ø  June 2012:  Donor-ID Web™, version 3.2; integration with biometric finger identification technology for use with donor search and staff login functionality

Ø  January 2015:  Donor-ID™ version 3.2.6; cumulative changes


Donor-IDä  is used to collect over 7,500,000 units of blood annually at 18 blood centers across the United States:  Gulf Coast Regional Blood Center in Houston, TX; Memorial Blood Center in St Paul, MN; Mississippi Blood Services in Jackson, MS; Oklahoma Blood Institute in Oklahoma City, OK; Coffee Memorial Blood Center in Amarillo, TX; Blood Bank of Delmarva in Newark, DE; Stanford Blood Center in Palo Alto, CA; ITxM with Central Blood Bank in Pittsburgh, PA and LifeSource Blood Services in Chicago, IL; LifeStream in San Bernardino, California; Dak-Minn Blood Bank in partnership with Altru Health System in Grand Forks, ND; ARUP Blood Services in Salt Lake City, UT; Heartland Blood Centers in Aurora, IL; Blood Center of Wisconsin in Milwaukee, WI; Central California Blood Center in Fresno, CA; Miller-Keystone Blood Center in Bethlehem, PA, Mid-South Regional Blood Center (Lifeblood®) in Memphis, TN and The American Red Cross, nationwide.  


(About Healthcare-ID) Incorporated in January 1995, Healthcare-ID develops and markets products to meet the Blood Center's need for automating the entry of accurate information at both fixed and mobile collection sites to eliminate the disposal of collected blood units based on donor eligibility and suitability, and significantly reduce the cost of blood collection.  Healthcare-ID, with its Donor-IDTM product offers modules including Registration, Health History Screening, CASI, Internet CASI, Physical Exam, Daily QC, Phlebotomy, Shipping, Survey, and Donor Adverse Reaction (as developed with the AABB Biovigilance committee)  Donor-IDTM interfaces to most major blood center data management systems. Visit www.healthcare-id.com for more information.


Established in 1971, Miller-Keystone Blood Center is an independent, not-for-profit, 501(c)(3) community organization that serves as the only blood provider to 26 hospitals in 12 counties in Pennsylvania and New Jersey.  Only blood donated through Miller-Keystone is transfused at these facilities.

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