DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Terumo BCT, Inc
Attention: Patti L. Arndt
10811 W. Collins Avenue
Lakewood, CO 80215
Trade/Device Name: Spectra Optia® Apheresis System
Regulation Number: 21 CFR 864.9245
Regulation Name: Automated blood cell separator
Regulatory Class: Class II
Product Code: GKT
Dated: November 27, 2012
Received: November 28, 2012
Dear Ms. Arndt:
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.
Celia M. Witten, Ph.D, M.D.
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Indications for Use Statement
510(k) Number: BK120076
Device Name: Spectra Optia® Apheresis System
Indications for Use:
The Spectra Optia® Apheresis System, a blood component separator, may be used to perform procedures for the collection of mononuclear cells (MNC) from peripheral blood.