Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Attention: Ms. Kathleen Crowder
Three Corporate Drive
Lake Zurich, IL 60047
Trade Name: Autopheresis-C Plasampheresis System
Regulation Number: 21 CFR 864.9245
Regulation Name: Automated Blood Cell Separator
Regulatory Class: Class II
Product Code: GKT
Dated: December 07, 2012
Received: December 10, 2012
Dear Ms. Crowder:
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 have any questions concerning the contents of the letter, please contact the Regulatory Project Manager, Alisha Miller, at (301) 827-3927.
Basil Golding, MD
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications for Use
Content of Labeling
Indications for Use
510(k) Number: BK120047
Device Name: Autopheresis-C Plasmapheresis System
The Autopheresis-C Plasmapheresis System is an automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. In the
US, the device has been cleared to collect:
- Fresh Frozen Plasma
- Must be prepared and placed in a freezer at -18 °C or colder within 8 hours of collection
- Source Plasma