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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

BK120039 Letter

September 4, 2012

Mediware Information Systems, Inc.
Attention: Mr. James C. McGaha
1900 Spring Road, Suite 450
Oak Brook, IL  60523

Re:     BK120039
Device Name:   LifeTrak® Version 2012
Regulation Name:  Stand Alone, Blood Bank Software
Regulatory Class:   Unclassified
Product Code:    MMH
Dated:   August 20, 2012
Received:   August 20, 2012

Dear Mr. McGaha:

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.  Please note: CBER does not evaluate information related to contract liability warranties.  We remind you, however, that device labeling must be truthful and not misleading.

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, ²Misbranding by reference to premarket notification²
(21 CFR 807.97).  For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 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.


Sincerely yours,

 

for
Richard J. Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research


Enclosure


 
Indications for Use


510(k) Number: BK120039

Device Name:  LifeTrak® Version 2012

Indications for Use:
 
LifeTrak®/Donor is a computerized system intended to be used by trained staff who are actively
engaged in functions that encompass:

• Maintaining a reliable donor database
• Rolling donor eligibility status
• Registering and auditing donations and deferrals
• On-line health history, physical findings, and donor questionnaire
• Inter-active donor questionnaire (staff and/or donor)
• Maintaining accurate records of communication with donors
• Donor notification
• HLA/RBC searching and matching
• Special donations registration
• Organizing mobile recruitment and tele-recruitment activities
• Planning, scheduling, and conducting drives
• Donor scheduling
• Scheduling collection staff
• Maintaining collection goals and calculating achievement statistics
• Production control and transportation for collection activities
• LifeTrak®/Donor is usable with wired/wireless networks supporting TCP/IP protocol

LifeTrak®/Lab is a comprehensive modular computerized system intended to be used by trained
personnel as a tool in the management of data related component production, testing, and
labeling of donated blood and testing of external samples. User access to individual modules is
controlled through defined access levels. Modules may be used independently and include the
following:

• Material check-in
• Component production
• Testing
• Labeling
• Special processing
• Nursing audit
• Testing services
• Imported blood processing

LifeTrak®/Distribution is a comprehensive modular computerized system intended to be used by
trained personnel as a tool in the management of data related to order entry and allocation,
pricing, order processing, inventory management, packaging and shipping, transfers, customer
debit/credit and quality services. User access to individual modules is controlled through defined
access levels. Modules may be used independently and include the following:

• Order Module
• Distribution Module
• Inventory Management
• Offline Data Entry
• Customer Credit/Debit