PLATELIA TOXO IGM KIT MODEL 26211

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. ## DEPARTMENT OF HEALTH & HUMAN SERVICES JUL - 1 2009 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Mr. David Bhend Regulatory Affairs Representative Bio-Rad Laboratories 6565 185th Ave. NW Redmond, WA 98052 Re: K090847 > Trade/Device Name: Bio-Rad Platelia™ Toxo IgM Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii serological reagents Regulatory Class: II Product Code: LGD Dated: June 26, 2009 Received: June 30, 2009 Dear Mr. Bhend: 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ Page 2 - 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR))), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sally attaym Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indication for Use 510(k) Number (if known): ' Device Name: Platelia™ Toxo IgM kit Indication For Use: The Platelia™ Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, Citrate) Note: - Patient testing with the Platelia™ Toxo IgM assay must be performed in 0 conjunction with an anti-Toxoplasma gondii IgG antibody assay. - The Platelia™ Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection. - The performance of the Platelia™ Toxo IgM assay has not been established for neonate testing. - The Platelia™ Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening. Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) And/Or Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) folgart Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) KM0047