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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK110023 Letter

June 8, 2011

CSL Behring AG
Attention: Ms. Karin Stein-Liesen
Wankdorfstrasse 10
3014 Bern
Switzerland

Re:
Product:
Product Name:
Regulatory Class:
Product Code:
Dated:
Received:
BK110023
System for Plasma Identification (SPI), version 3.1.0
Software, Blood Bank, Stand Alone
Unclassified
MMH
May 13, 2011
May 16, 2011

Dear Ms. Stein-Liesen:

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 807); labeling (21 CFR 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 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 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
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 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.

Sincerely yours,

/signature/

for Richard J Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research 


Indications for Use

510(k) Number:
Device Name:
BK110023
System for Plasma Identification (SPI), version 3.1.0

Indications For Use:

The SPI System will offer the following controls to the facilities specified:

1. Center
  o Upload unit, carton and shipment information from collection facility data systems via electronic interface.
  o Create unit, carton and shipment information manually as necessary.
  o Identify and assign ancillary shipment contents, supplies and test kits.
  o Specify shipping statements as required by the fractionator to receive shipments processed.
  o Format and generate carton identification and shipping labels.
  o Record and resolve unit, carton and shipment discrepancies.
  o Create and iterate the status of post donation information notes.
  o Create staff members eligible to access the Center module of SPI.
  o Restrict shipment from center based on minimum testing requirement.
2. Consignee
  o Receive shipments from collection facilities.
  o Raise and report shipment and carton discrepancies.
  o Load cartons into containers designed and prepared by the fractionator.
  o Generate shipping documentation.
  o Process shipments to fractionator.
  o Report and investigate container discrepancies.
3. Fractionator
  o Design containers to be loaded by and received from consignees.
  o Consolidate shipments received from consignees.
  o Receive shipments from consignees and verify containers received.
  o Scan shipments into bins manually or via conveyor.
  o Label and sequence pools.
  o Transfer shipments, cartons and bins between storage locations.
  o Receive and follow post donation information notes to resolution.
  o Design pools and pool plasma as required.
  o Receive test results and resolve associated discrepancies.
4. Testing Laboratory
  o Electronically receive test result information from testing laboratories.