Attention: Cheryl Chamberlain Roscher, Ph.D.
Three Corporate Drive
Lake Zurich, IL 60047
|Device Name:||AMICUS® Separator System|
|Regulation Number:||21 CFR 864.9245|
|Regulation Name:||Automated blood cell separator|
|Regulatory Class:||Class II|
Dear Dr. Chamberlain Roscher:
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 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/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. 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.
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.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Indications for Use
510(k) Number: BK100044
Device Name: AMICUS® Separator System
Indications For Use:
The AMICUS Separator System is automated blood cell separator indicated for collection of blood components and mononuclear cells.
The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post-platelet count greater than or equal to 100,000 platelets/uL.
Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:
- Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
- Platelets Pheresis, Leukocytes Reduced, Platelets Additive Solution (InterSol) (single, double or triple units)
- Fresh Frozen Plasma (FFP)
- Source Plasma
- Red Blood Cells, Leukocytes Reduced (by apheresis)
- Mononuclear Cells
Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction standards. This does not apply to Platelets Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).