Mediware Information Systems, Inc.
Attention: Mr. James C. McGaha
1900 Spring Road, Suite 450
Oak Brook, IL 60523
Device Name: HCLLTM Transfusion 2012
Regulation Name: Stand Alone, Blood Bank Software
Regulatory Class: Unclassified
Product Code: MMH
Dated: September 12, 2012
Received: September 13, 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, "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: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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: BK120036
Device Name: HCLLTM Transfusion 2012
Indications for Use:
HCLLTM Transfusion 2012 is intended to address all phases of transfusion service activities, and assists transfusion service personnel:
- Maintain a reliable patient database
- Manually and electronically register, admit and transfer patients
- Manually and electronically receive patient orders
- Manipulate and label products
- Print ABC Codabar and ISBT 128 blood labels
- Perform electronic crossmatch
- Issue blood products under normal and emergency conditions
- Receive inventory
- Ship specimens, reagents, derivatives and blood products
- Receive and test patient and unit specimens
- Interface to blood bank testing instruments (bi-directional)
- Interface to blood storage devices (bi-directional)