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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120069 Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 May 31, 2013

 

BioLife Plasma Services L.P.
Attention: Ms. Julie Quick
One Baxter Parkway, DF3-1E
Deerfield, IL 60015
 
Re:                                         BK120069
Device Name:                         Automated Plasma Dispositioning System (APDS) v1.0
Regulation Name:                              Stand Alone, Blood Bank Software
Regulatory Class:                   Unclassified
Product Code:                         MMH
Dated:                                     May 21, 2013
Received:                                May 22, 2013
 
Dear Ms. Quick:
 
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, ²Misbranding by reference to premarket notification² (21CFR 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. 
 
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,
 
 /s/
 
Richard J. Davey, MD
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
   Evaluation and Research       
 
Enclosure
Indications For Use



 

Indications for Use
 
510(k) Number:          BK120069
 
Device Name:                         Automated Plasma Dispositioning System (APDS) v1.0
 
Indications for Use:
 
The Automated Plasma Dispositioning System (APDS) is used to receive, analyze, and store data
for human plasma collected and shipped between facilities such as collection sites, warehouses
and fractionation facilities.  The system tracks data received from suppliers, verifying each
plasma units’ suitability for further manufacture. The verification criteria is entered into the
system through file and/or data transfers.  The Manufacturing Execution System (MES)/Sorting
Line component of APDS, consisting of hardware equipment (sorting line) and software (MES),
sorts plasma units based on acceptance criteria designed into the system.