ELECSYS RUBELLA IGGA CALCHECK 5

{0}------------------------------------------------ K092555 OCT 3 0 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3952 | | | Contact Person: Kelly French<br>Phone: 317-521-3208<br>Fax: 317-521-2324<br>Email: kelly.french@roche.com | | | Secondary Contact: Stephanie Greeman<br>Phone: 317-521-2458<br>Fax: 317-521-2324<br>Email: stephanie.greeman@roche.com | | | Date Prepared: August 21, 2009 | | Device Name | Proprietary name: Elecsys Rubella IgG CalCheck 5<br>Common name: Rubella IgG CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and unassayed) | | Predicate device | The Elecsys Rubella IgG CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys Rubella IgG CalCheck (K090311). | | Device Description | The Elecsys Rubella IgG CalCheck 5 is a lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | {1}------------------------------------------------ Intended use The Elecsys Rubella IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers. 510(k) Summary, Continued The table below compares Elecsys Rubella IgG CalCheck 5 with the Comparison Table predicate device, Elecsys Rubella IgG Calcheck (K090311). | Characteristic | Elecsys Rubella IgG CalCheck<br>(K090311) | Elecsys Rubella IgG<br>CalCheck 5 | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Elecsys Rubella IgG CalCheck<br>is an assayed calibrator control<br>intended for use in the verification<br>of the calibration established by the<br>Elecsys Rubella IgG reagent on the<br>Elecsys 2010, MODULAR<br>ANALYTICS E170 and cobas e<br>immunoassay analyzers. | The Elecsys Rubella IgG CalCheck<br>5 is an assayed control for use in<br>calibration verification and for use<br>in the verification of the assay range<br>established by the Elecsys Rubella<br>IgG reagent on the Elecsys 2010,<br>MODULAR ANALYTICS E170<br>and cobas e immunoassay<br>analyzers. | | Levels | Three | Five | | 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 mix gently by<br>inversion. | Same | | Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 20 – 25°C : 4 hrs | Same | | Matrix | Human serum matrix | Same | Performance Characteristics The Elecsys Rubella IgG CalCheck 5 was evaluated for value assignment and stability. {2}------------------------------------------------ Image /page/2/Picture/0 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 a stylized symbol of three overlapping lines, resembling a human figure. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 Kelly French Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN, 46250-3831 OCT 3 0 2009 K 092585 Re: | Trade/Device Name: | Elecsys Rubella IgG CalCheck 5 | |--------------------|--------------------------------------------------| | Regulation Number: | 21CFR §862.1660 | | | 21CFR §866.3510 | | Regulation Name: | Quality Control Material (assayed and unassayed) | | | Rubella Virus Serological Reagents | | Regulatory Class: | Class I (Quality Control) | | | Class II (Rubella IgG) | | Product Code: | JJX, LFX | | Dated: | August 21, 2009 | | Received: | August 24, 2009 | 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. {3}------------------------------------------------ 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). 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, Vaisattaygus 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 10.92585 510(k) Number (if known): Device Name: Elecsys Rubella IgG CalCheck 5 Indication For Use: The Elecsys Rubella IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers. Prescription Use X (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 (OIVD) Uve Schuf Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k092585 Page 1 of 1