ELECSYS RUBELLA IGG CALCHECK

{0}------------------------------------------------ K090311 ## 510(k) Summary MAY - 5 2009 | Introduction | According to the requirements of 21 CFR 807.92, the following<br>information provides details to understand the basis for a<br>determination of substantial equivalence. | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3208<br><br>Contact Person: Kelly French<br><br>Date Prepared: February 2, 2009 | | Device Name | Proprietary name: Elecsys Rubella IgG CalCheck<br><br>Common name: Rubella IgG CalCheck<br><br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) | | Device Description | The Elecsys Rubella IgG CalCheck is a lyophilized product<br>consisting of human anti-Rubella IgG antibodies in human serum<br>matrix. During manufacture, the analyte is spiked into the matrix at<br>the desired concentration levels. | | Intended use | The Elecsys Rubella IgG CalCheck is an assayed calibrator control<br>intended for use in the verification of the calibration established by<br>the Elecsys Rubella IgG reagent on the Elecsys 2010, the<br>MODULAR ANALYTICS E170, and cobas e immunoassay<br>analyzers. | | Comparison Table | The table below compares Elecsys Rubella IgG CalCheck with the<br>predicate device, Elecsys C-Peptide Calcheck (K040157). | | Characteristic | Elecsys C-Peptide CalCheck<br>(K040157) | Elecsys Rubella IgG<br>CalCheck | |----------------|-----------------------------------------|---------------------------------------------------------------| | Intended Use | For use in the verification of the | For use in the verification of<br>the calibration established | {1}------------------------------------------------ | Characteristic | Elecsys C-Peptide CalCheck<br>(K040157) | Elecsys Rubella IgG<br>CalCheck | |----------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | | calibration established by the Elecsys<br>C-Peptide reagent on the Elecsys and<br>cobas e immunoassay analyzers. | by the Elecsys Rubella IgG<br>reagent on the Elecsys<br>2010, the MODULAR<br>ANALYTICS E170, and<br>cobas e immunoassay<br>analyzers. | | Levels | Three | Same | | Format | Lyophilized | Same | | Handling | Reconstitute with exactly 1.0 mL<br>distilled or deionized water and allow<br>standing closed for 15 minutes, then<br>mix gently. | Same | | Stability | Unopened:<br>Store at 2-8°C until expiration date<br>Reconstituted:<br>20 - 25°C: 4 hrs | Same | | Matrix | Equine serum matrix | Human Serum | Performance Characteristics . : The Elecsys Rubella 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 image of an eagle or bird-like figure, with its wings forming three distinct, curved shapes. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Kelly French Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Haguc Road PO Box 50416 Indianapolis, IN, 46250-3831 | : | K090311 | |--------------------|----------------------------------------------------------------------------------------| | Trade/Device Name: | Elecsys Rubella IgG CalCheck | | Regulation Number: | 21CFR §866.1660<br>21CFR §866.3510 | | Regulation Name: | Quality control material (assayed and unassayed)<br>Rubella virus serological reagents | | Regulatory Class: | Class I reserved (quality control)<br>Class II (Rubella IgG) | | Product Code: | JJX<br>LFX | | Dated: | February 5, 2009 | | Received: | February 6, 2009 | MAY - 5 2009 ## Dear Ms. French: Re: 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 {3}------------------------------------------------ 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 attgins 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 510(k) Number (if known): K090311 Device Name: Elecsys Rubella İgG CalCheck Indication For Use: The Elecsys Rubella IgG CalCheck is an assayed calibrator control intended for use in the verification of the calibration 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) Uwe Schef Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 2090311 510(k)