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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK080010 Letter

June 27, 2008

Gambro BCT, Inc.
Attention: Ms. Kathryn Coressel
10811 W. Collins Ave.
Lakewood , CO 80215-4498

Re: BK080010
Product: The Atreus Whole Blood Processing System
Date Received: 13-MAR-08
Classification: II
Device Code: GKT

Dear Ms. Coressel:

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 .

Sincerely yours,

-- signature --

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure


 

Indications for Use

510(k) Number: BK080010
Device Name: The Atreus Whole Blood Processing System

Indications For Use:

The Atreus® Whole Blood Processing System is indicated for the automatic separation of one unit of CPD Whole Blood into two transfusable components:

  • Plasma or Plasma, Leukocytes Reduced (by Atreus® centrifugation) and
  • CPD/AS-3 Red Blood Cells, Leukocytes Reduced (by manual gravity leukocyte reduction filtration).

The Atreus® Whole Blood Processing System is intended to be used with an Atreus® System Manager.

The Atreus® Whole Blood Processing System is intended to be used with a disposable processing set with a leukoreduction filter, which does not contain anticoagulant or storage solutions (dry set).

The Atreus® Whole Blood Processing System is intended to be used with a CPD Whole Blood collection bag that is FDA approved for the collection of 500 mL of Whole Blood.

Studies have not been performed to support freezing or gamma irradiation of CPD/AS-3 RBC products.