ELECSYS TOXO IGG CALCHECK

{0}------------------------------------------------ K083655 FEB 1 2 2009 # 510(k) Summary Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter name, address, contact Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 317-521-3208 Contact Person: Kelly French Date Prepared: November 20, 2008 Device Name Proprietary name: Elecsys Toxo IgG CalCheck Common name: Toxo IgG CalCheck Classification name: Single (specified) analyte controls (assayed and unassayed) Predicate device The Elecsys Toxo IgG CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck (K040157). The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of Device human anti-Toxo IgG antibodies in human serum matrix. During Description manufacture, the analytes are spiked into the matrix at the desired concentration levels. For use in the verification of the calibration established by the Elecsys Toxo Intended use IgG reagent on the Elecsys and cobas e immunoassay analyzers. Continued on next page {1}------------------------------------------------ ### 510(k) Summary, Continued The table below compares Elecsys Toxo IgG CalCheck with the predicate Comparison device, Elecsys C-Peptide Calcheck (K040157). Table and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the | Characteristic | Elecsys C- Peptide CalCheck<br>(K040157) | Elecsys Toxo IgG CalCheck | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For use in the verification of the<br>calibration established by the<br>Elecsys C-Peptide reagent on the<br>Elecsys and cobas e immunoassay<br>analyzers. | For use in the verification of the<br>calibration established by the Elecsys<br>Toxo IgG reagent on the Elecsys and<br>cobas e immunoassay analyzers. | | Levels | Three | Same | | Format | Lyophilized | Same | | Handling | Reconstitute with exactly 1.0 mL<br>distilled or deionized water and<br>allow standing closed for 15<br>minutes, then mixing gently. | Same | | Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 20 - 25 °C : 4 hrs | Same | | Matrix | equine serum matrix | Human serum | Performance Characteristics The Elecsys Toxo IgG CalCheck was evaluated for value assignment and stability. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Kelly French Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-3831 . Re: K083655 > Trade/Device Name: Elecsys Toxo IgG CalCheck Regulation Number: 21 CFR 862.1660 21 CFR 866.3780 Regulation Name: Quality control material (assayed and unassayed) Toxoplasma gondii serological reagents FEB 1 2 2009 Regulatory Class: I, II Product Code: JJX, LGD Dated: December 9, 2008 Received: December 10, 2008 #### Dear Ms. French: 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 (OS) regulation (21 CFR Part 820). {3}------------------------------------------------ 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Felly A. Uejinet, M.D., Ph.D. 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 {4}------------------------------------------------ ## Indication for Use K083653 510(k) Number (if known): Device Name: Elecsys Toxo IgG CalCheck Indication For Use: The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers. ਮ Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) freddie hi. Poole Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K083653