August 12, 2013
Attention: Andrew E. Levin, PhD
27 Drydock Avenue, 6th Floor
Boston, MA 02210
|Trade/Device Name:||BacTx® Bacterial Detection Kit for Platelets|
|Regulation Name:||Bacterial Detection Systems for Platelet Transfusion Products|
|Dated:||August 7, 2013|
|Received:||August 7, 2013|
Dear Dr. Levin:
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. 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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.
On Behalf of
Basil Golding, MD
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Indications for Use
|Device Name:||BacTx® Bacterial Detection Kit for Platelets|
Indications For Use:
The Immunetics BacTx® Bacterial Detection Kit for detection of bacteria in platelets is a rapid, qualitative, colorimetric, quality control test for the detection of aerobic and anaerobic, Gram positive and Gram-negative bacteria in:
- leukocyte reduced apheresis platelet units (LRAP) (Apheresis Platelets Leukocytes Reduced) as a quality control test following testing with a growth based bacterial detection device cleared by the FDA for quality control testing of leukocyte reduced apheresis platelets and;
- pools of up to six (6) units of leukocyte reduced whole blood-derived platelets (Platelets, Leukocytes Reduced) that are pooled within four (4) hours of transfusion.