DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Haemonetics Software Solutions
Attention: Ms. Christina Thomas
4925 Robert J. Mathews Parkway
El Dorado Hills, CA 95762
Trade/Device Name: Phlebotomy System 1.0.0
Regulation Name: Stand Alone, Blood Bank Software
Regulatory Class: Unclassified
Product Code: MMH
Dated: March 31, 2013
Received: April 1, 2013
Dear Ms. Diaz:
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 Part 807); labeling (21 CFR Part 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 Part 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 for your device on our labeling regulation (21 CFR Part 801), please contact 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
. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 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, MD
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications For Use
Indications for Use
510(k) Number: BK120084
Device Name: Phlebotomy System 1.0.0
Indications For Use:
Phlebotomy is a tool that is intended to allow users to collect draw related data. Phlebotomy provides the following:
- Electronic paperless collection of draw related data with multi-lingual capabilities.
- Provide users the display of additionally available donor identification information that may optionally be used by the phlebotomist to establish positive donor identification.
- Provide phlebotomists the ability to capture notations and staff assessment outcomes associated with unsuitable draw conditions.
- User interface design provides users the option of accessing the tool from commercially available wireless FCC and CE marked devices.
- Exchange of donor information with a collection facility’s information system.
- Configurable workflow per collection type.
- Enables workflow enforcement.
- Printing of records and reports.
- Comprehensive auditing and security features.