Company: Fresenius Se
Subject: Premarket Approval/Misbranded/Adulterated
Issuer: Center for Devices and Radiological Health
Issued: Jan. 28, 2011 Closed:
Not Issued
Source ucm242416 Archive Code:

Fresenius Se 1/28/11

Department of Health and Human Services

Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

JAN 28 2011

VIA United Parcel Service

Warning Letter

Dr. Ulf M. Schneider
Chairman of the Management Board
Fresenius SE
61346 Bad Homburg v.d.H.

RE: Red Blood Cell Set, AS104
Refer to GEN1 001508 when replying to this letter

Dear Dr. Schneider:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Red Blood Cell (RBC) Set, and the AS104 Blood Cell Separator (AS104) in conjunction with the RBC Set, in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under Section 201 (h) of the Act, 21 U.S.C. 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body. The Office of Compliance (OC) in the Center for Devices and Radiological Health (CRDH) reviewed documents provided by your firm to the FDA Seattle office, for the RBC Set and the AS104 Blood Cell Separator.

Review of our records indicates that a premarket notification (510(k)) for the AS104 Blood Cell Separator and bloodlines for therapeutic plasma exchange (TPE) was cleared November 2, 1990 (K895435). We cleared the AS104 solely to perform therapeutic plasma exchange (TPE) and bloodlines used to perform TPE were cleared. No labeling claims for therapeutic RBC exchange were cleared for the AS104 system. Further, the tubing sets necessary to perform the RBC exchange treatments were not cleared for marketing. We note that your submission K895435 initially included a range of plasma and cell separation modalities, including RBC exchange; however, during the course of its review, the labeling was restricted to only indicate TPE and that you provided that the only disposable tubing set to be marketed with the AS104 through this 510(k) application was the PL-1 tubing set for therapeutic plasma separation. We also note that the Com.Tec system, K060734, cleared September 5, 2006, was cleared solely to perform TPE. We note that, during the September 11, 2008, inspection of Fresenius Kabi, LLC, you informed our investigator that the AS104 cell separator is no longer being manufactured but that users continue to operate it within the United States and that you provide service and repairs for this device.

You have provided information to the FDA Seattle District Office, on November 15, 2010, December 6, 2010, and December 9, 2010, that

1. The Fresenius RBC red blood cell set is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

2. The Fresenius RBC set is marketed as Catalog Number 9007601.

3. The RBC sets, article no 9007601, are used in conjunction with the AS104 cell separator, for therapeutic red cell exchange in patients suffering from sickle cell disease.

4. You have marketed and distributed RBC Sets in the United States.

The RBC Set, and the AS104 when promoted for use for RBC exchange, are adulterated under Section 501 (f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(8), because you do not have approved applications for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. 360(a), or approved applications for investigational device exemptions (IDE) under Section 520(g) of the Act, 21 U.S.C. 360j(g), for the new intended uses. The RBC Set is also misbranded under Section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by Section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency (21 U.S.C. 807.81 (b)).

The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at . The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

The Office of Compliance requests that Fresenius immediately cease the dissemination of promotional materials for the RBC Set and for the AS104 when promoted for use for RBC exchange, the same as or similar to those described above. You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for Red Blood Cell Set and the AS104 the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.

Please direct your response to Paul F. Tilton at the Food and Drug Administration, 10903 New Hampshire Ave., W066-3540, Silver Spring, MD 20993, facsimile at (301) 847-8137. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Red Blood Cell Set and the AS104 comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely yours,
Steven D. Silverman
Office of Compliance
Center for Devices and
Radiological Health

Dr. Thomas Graf
Fresenius HemoCare Netherlands B.V.
Runde zz 41
NL-7881 HM Emmer-Compascuum, NL-DR
The Netherlands

Ms. Katherine J. Sivertson
Director of Transfusion Technology North America
Fresenius Kabi, LLC
8653 154th Ave. NE
Redmond, WA 98052