ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)

{0}------------------------------------------------ MAY - 4 2011 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990. The assigned 510(k) Number is: K102681 #### 1. Manufacturer's Name, Address, Telephone, and Contact Person | Manufacturer: | Siemens Healthcare Diagnostics Inc. | |-----------------|-------------------------------------------------| | Address: | 511 Benedict Avenue<br>Tarrytown, NY 10591-5097 | | Contact Person: | Matthew Gee<br>Senior Regulatory Specialist | | Phone: | 914-524-2099 | | Fax: | 924-524-2500 | | Email: | matthew.gee@siemens.com | # 2. Date Summary Prepared June 11, 2010 # 3. Device Trade Name / Common Name / Classification Name | Trade Name: | ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay | |----------------------|--------------------------------------------------------| | Common Name: | Immunoassay, Toxoplasma Gondii IgG | | Classification Name: | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | | FDA Classification: | Class II (Special Controls) | | Review Panel: | Microbiology | | Product Code: | LGD | | Regulation Number: | 866.3780 | #### 4. Predicate (Unmodified) Device | Device Name: | ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay | |----------------|-----------------------------------------------------------------------------| | Manufacturer: | Siemens Healthcare Diagnostics Inc.<br>(previously Bayer Diagnostics Corp.) | | 510(k) Number: | K012183 | {1}------------------------------------------------ ## 5. Intended Use of Predicate (Unmodified) Device The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma. WARNING: The use of the ADVIA Centaur Toxoplasma IgG assay to diagnose recent infection by testing acute and convalescent samples is not recommended. The calculated values for toxoplasma lgG in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the toxoplasma IgG assay used. Values obtained with different assay methods cannot be used interchangeably. This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors. Testing should not be performed as a screening procedure for the general population. #### 6. Intended Use of Modified Device The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utlized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma. WARNING: The use of the ADVIA Centaur Toxoplasma IgG assay to diagnose recent infection by testing acute and convalescent samples is not recommended. The calculated values for toxoplasma IgG in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the toxoplasma IgG assay used. Values obtained with different assay methods cannot be used interchangeably. This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors. Testing should not be performed as a screening procedure for the general population. {2}------------------------------------------------ ## 7. Device Description The modified ADVIA Centaur Toxo G Assay is comprised of the following: ADVIA Centaur Toxo G ReadyPack® Primary Reagent Pack, including: ADVIA Centaur Toxo G Lite Reagent (10.0 mL/reagent pack) purified T. gondii p30 antigen (~0.75 µg/mL) complexed with mouse antip30 monoclonal antibody (F(ab)2 fragment) labeled with acridinium ester in protein buffer with surfactant and preservatives ADVIA Centaur Toxo G Solid Phase (25.0 mL/reagent pack) mouse anti-human IgGE monoclonal antibody (~0.3 mg/mL) covalently coupled to paramagnetic particles in protein buffer with surfactant and preservatives ADVIA Centaur Toxo G Calibrators (1.0 mL/vial) processed defibrinated human plasma positive for toxoplasma IgG antibodies with preservatives ADVIA Centaur Toxo G Quality Control Material (2.7 mL/vial) processed defibrinated human plasma negative and positive for toxoplasma igG antibodies with preservatives ## 8. Similarities and Differences between Predicate and Modified Devices | Feature | Predicate (Unmodified)<br>ToxoG Assay (K012183) | Modified<br>ToxoG Assay | |--------------------|-------------------------------------------------|-------------------------------------------| | Intended Use | See Section 5 | Same - See Section 6 | | Sample Type | Serum, Heparinized Plasma,<br>EDTA Plasma | Serum, Heparinized Plasma, EDTA<br>Plasma | | Sample Volume | 10 UL | 10 µL | | Assay Range | 0.5-700 IU/mL | 0.5-700 IU/mL | | Performance Claims | See Instructions for Use | Unchanged | #### Table 1. Similarities between Current and Modified ADVIA Centaur Toxo G Assays {3}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness | Feature | Predicate (Unmodified)<br>ToxoG Assay (K012183) | Modified<br>ToxoG Assay | |------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------| | Lite Reagent Conjugate<br>p30 Ag Concentration | 1.5 µg/mL | 0.75 µg/mL | | Lite Reagent Conjugate<br>Loading Ratio | 30:1 | 18:1 | | Lite Reagent Antibody<br>Format | Whole IgG | F(ab)2 Fragment recognizing same<br>epitope as current assay | | Mouse IgG Concentration | Lite Reagent Buffer<br>800 mg/L | Lite Reagent Buffer<br>400 mg/L | | | Solid Phase Buffer<br>none | Solid Phase Buffer<br>400 mg/L | | PEG8000 in Solid Phase | none | 20 g/L | | Tween20 in Solid Phase | none | 5 g/L | #### 9. Substantial Equivalence The modified ADVIA Centaur Toxo G assay has the same operating principles, assay performance characteristics and intended use as the predicate device. The results of performance testing, and verification and validation activities demonstrate that the design modifications to the ADVIA Centaur Toxo G assay do not impact its safety or effectiveness and do not alter its performance claims. The modified assay is substantially equivalent to the currently-marketed predicate ADVIA Centaur Toxo G assay. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or other winged creature, with its head facing left and its wings spread upward. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Siemens Healthcare Diagnostics Inc. c/o Mr. Matthew Gee Senior Regulatory Specialist 511 Benedict Avenue Tarrytown, NY 10591-5097 MAY - 4 2011 Re: K102681 Trade/Device Name: ADIVA Centaur® Toxoplasma IgG (Toxo G) Assay Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: April 13, 2011 Received: April 14, 2011 Dear Mr. Gee 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. ff 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 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); 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 {5}------------------------------------------------ Page 2 - Mr. Matthew Gee 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 Sufety 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/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/cdrh/industry/support/index.html. Sincerely vours. Sally A. Hojvat, 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 Image /page/5/Picture/9 description: The image shows a black and white map of a chain of islands. The islands are small and scattered, stretching diagonally across the frame from the upper left to the lower right. The islands are surrounded by white space, suggesting they are in the ocean. {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K102681 Device Name: ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay #### Indications For Use: The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OIVD) Fredda. Pade Division Sign-Off Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 11 . Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K102681