September 4, 2008
Attention: Mr. Michael Chang
400 Wood Road
Braintree MA 02184 -9144
Product: MCS+ 9000 System
Date Received: 05-AUG-08
Device Code: GKT
Dear Mr. Chang:
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, ² Misbranding by reference to premarket notification ² (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 .
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research
510(k) Number: BK080038
Device Name: MCS+ 9000 System
Indications For Use:
The MCS+ 9000 System with wireless capable modification is intended for use as an automated blood cell separator system and blood component collector in conjunction with single use sterile disposable sets. Products that can be collected using the MCS+ 9000 System include single donor platelets and concurrent plasma.
The LN994 is a functionally closed system intended to be used to collect one unit of Platelets, Pheresis with or without Plasma, or two units of Platelets, Pheresis from donors using the MCS+ LN9000.
The LN994CF and LN994CF-CPP are functionally closed systems intended to be used to collect one unit of Platelets, Pheresis Leukocyte Reduced with or without Plasma, or two units of Platelets, Pheresis, Leukocyte Reduced from donors using the MCS+ LN9000.