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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120065 Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


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

 

Haemonetics Corporation
Attention:  Ms. Julie Ryan
400 Wood Road
Braintree, MA 02184
 
Re:                              BK120065
Trade Name:               PCS2 Plasma Collection System
Regulation Number:  21 CFR 864.9245
Regulation Name:      Automated Blood Cell Separator
Regulatory Class:       Class II
Product Code:             GKT
Dated:                         October 30, 2012
Received:                    November 1, 2012
 
Dear Ms. Ryan:
 
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 (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
go to http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. 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.
 
If you have any questions concerning the contents of the letter, please contact the Regulatory
Project Manager, Alisha Miller, at (301) 827-3927.
 
Sincerely yours,
 
 
 
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research
 
 
 
Enclosure



Indications for Use
 
510(k) Number: BK120065
 
Device Name: PCS2 Plasma Collection System
 
Indications for Use:
 
The PCS2 System is intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets. Products that can be collected using the PCS2 System LN6002 automated cell separator include source plasma, plasma for reinfusion and plasma & leukocytes.
 
Products that can be collected using the PCS2 LN6002 System with software revision K.1 are source plasma and plasma for reinfusion only.
 
The LN625HS and LN625B are disposable centrifuge bowls designed for use with the PCS2 LN6002 and the LN620 Disposable Harness, for the collection of source plasma and plasma for reinfusion, with or without saline compensation.