HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of flowing lines. 10903 New Hampshire Avenue Silver Spring, MD 20993 The Binding Site Group, Ltd. c/o Ms. Marianne Sender, Regulatory Affairs 8 Calthorpe Rd, Edgbaston Birmingham, B15 1QT United Kingdom JUL 1 1 2012 Re: k113349 Trade/Device Name: Human CH50 reagent pack for use on the SPAPLUS Human CH50 calibrator set for use on the SPAPLUS Human CH50 controls for use on the SPAPLUS Regulation Number: 21 CFR §866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: DAE, JIX, JJY Dated: July 6, 2012 Received: July 11, 2012 Dear Ms. Sender: 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any I outhal the Act's requirements, including, but not limited to: registration and listing (21 {1}------------------------------------------------ Page 2 - Ms. Marianne Sender CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/cdrh/industry/support/index.html. Sincerely yours, ia m chan Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Devices Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k113349 Human CH50 reagent pack for use on the SPA pLus Device Name: Human CH50 calibrator set for use on the SPA plus Human CH50 controls for use on the SPA plus Indications For Use: ## Human CH50 reagent pack for use on the SPA plus. These reagents are intended for the quantification of total classical complement activity (CH50) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests. Human CH50 calibrator set for use on the SPA plus The Human CH50 calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH50 reagent pack (product code: NK095.S) for the determination of total complement activity. ## Human CH50 controls for use on the SPA plus. The Human CH50 controls are intended for use in conjunction with the Binding Site Human CH50 reagent pack for use on the SPAPLUS (product code: NK095.S). × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510K K113349