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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

BK120022 Letter

 

Hemo bioscience
Attention: Mr. Noel Brown
801 Capitola Drive, Suite 9
Durham, NC 27713
 
Re:   BK120022
         Trade/Device Name: C3 Control Cells
         Regulation Number: 21 CFR 864.9650
         Regulation Name: Quality control kits for blood banking reagents
         Regulatory Class: Class II
         Product Code: KSF
        Dated: September 17, 2012
        Received: September 19, 2012
 
Dear Mr. Brown:
 
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.
 
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 desire specific advice for your device on our labeling regulation (21 CFR Part 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, ²Misbranding by reference to premarket notification² (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 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.
 
If you have any questions concerning the contents of the letter, please contact the Regulatory Project Manager, Alisha Miller, at (301) 827-3927. 
 
Sincerely yours,
 
 /s/
 
Richard J. Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics 
 Evaluation and Research
 
                                                                       
Enclosures:
Indications for Use
Package Insert

 


 
                                                            Indications for Use                                                                           
510(k) Number: BK120022
 
Device Name: C3 Control Cells
 
Indications for Use:
 
Hemo bioscience C3 Control Cells are used as a control of the antiglobulin test performed with Anti-Human Globulin containing anti-C3.