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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK060033 Letter

March 27, 2008

Haemonetics Corporation
Attention: Mr. Gabriel Muraca, Jr.
400 Wood Road
Braintree, MA  02184

Re:                  BK060033

Product:           Haemonetics PCS 2 Plasma Collection System, Wireless (W) Capable Modification

Date Received:  14-JUN-06

Classification:    II

Device Code:     GKT

Dear Mr. Muraca:

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.

If your device has been classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 (21CFR Part 807.97). 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) 835-4709 or (301) 827-1800 or at its Internet address: http://www.fda.gov/cber/smlbus.htm.

Sincerely yours,

 

Elizabeth Callaghan
Acting Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure


Indications for Use                                

 

510(k) Number: BK060033                              

 

Device Name: Haemonetics® PCS® 2 Plasma Collection System, Wireless (W) Capable Modification

                       

Indications For Use:

 

The PCS2 System with wireless capable modification is intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets. Products currently approved for collection using the PCS2 automated cell separator include source plasma, plasma for reinfusion, and plasma A leukocytes. The indications for use for the wireless capable modified PCS2 are the same as the currently marketed PCS2 system.

 

The device is intended for use by trained medical personnel under the direction of a physician. The attending physician is responsible for the proper use of the device. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as “Rx only”.