Elecsys Estradiol III CalSet

{0}------------------------------------------------ # 510(k) Summary, Elecsys Estradiol III CalSet **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. | <b>Device Name</b> | <b>Proprietary name:</b> | Elecsys Estradiol III CalSet | |--------------------|--------------------------|----------------------------------------| | | <b>Common name:</b> | Estradiol III CalSet | | | <b>Classification:</b> | 21 CFR 862.1150, Calibrator, Secondary | | | <b>Product Code:</b> | JIT | For the Estradiol III CalSet, the establishment registration number for Establishment Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for Registration Penzberg, Germany, is 9610529. The establishment registration number for Roche Diagnostics United States is 1823260. Classification FDA has classified the product as a Class II device. | Product Name | Panel | Product Code | Classification Name | Regulation Citation | |-------------------------|-----------------------|--------------|--------------------------|---------------------| | Estradiol III<br>CalSet | Clinical<br>Chemistry | JIT | Calibrator,<br>Secondary | 21 CFR 862.1150 | {1}------------------------------------------------ | Device<br>Description | Elecsys Estradiol III CalSet:<br>• The Elecsys Estradiol III CalSet is a lyophilized product consisting of<br>synthetic Estradiol in a human serum matrix. It has been standardized<br>against ID-GC/MS (isotope dilution gas chromatography mass<br>spectrometry). | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Elecsys Estradiol III CalSet:<br>• Estradiol III CalSet is used for calibrating the quantitative Elecsys<br>Estradiol III assay on the Elecsys and cobas e immunoassay analyzers. | | Predicate<br>device | The Elecsys Estradiol III CalSet is substantially equivalent to the predicate<br>device, Elecsys Estradiol II CalSet II (K992981). | | Substantial<br>Equivalence<br>Comparison | The following tables compare the Elecsys Estradiol III CalSet with the<br>predicate device. | {2}------------------------------------------------ Comparison The table below compares Elecsys Estradiol III CalSet with the predicate device, Table Elecsys Estradiol II CalSet II (K992981). The change in the new product was a shift in the Cal 2 target value. ### Table | Characteristic | Elecsys Estradiol III CalSet<br>(Candidate) | Elecsys Estradiol II CalSet II<br>(K992981) | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Estradiol III CalSet is used for<br>calibrating the quantitative<br>Elecsys Estradiol III assay on<br>the Elecsys and cobas e<br>immunoassay analyzers. | Estradiol II CalSet II is used for<br>calibrating the quantitative<br>Elecsys Estradiol II assay on the<br>Elecsys and cobas e<br>immunoassay analyzers. | | Analyte | Estradiol (synthetic) | Same | | Matrix | Human serum matrix | Same | | Levels | Two | Same | | Target Ranges | Cal 1: 20 pg/mL<br>Cal 2: 2000 pg/mL | Cal 1: 20 pg/mL<br>Cal 2: 3000 pg/mL | | Format | Lyophilized | Same | | Handling | Carefully dissolve the contents<br>of one bottle by adding exactly<br>1.0 mL of distilled or deionized<br>water and allow to stand closed<br>for 15 minutes to reconstitute.<br>Mix carefully, avoiding the<br>foam formation.<br>Transfer aliquots of the<br>reconstituted calibrators into<br>empty labeled snap-cap bottles<br>(CalSet Vials). Attach the<br>supplied labels to the additional<br>bottles. Store the aliquots<br>immediately at -20°C.<br>Perform only one calibration<br>procedure per aliquot. | Same. | | Table continued | | | | Characteristic | Elecsys Estradiol III CalSet<br>(Candidate) | Elecsys Estradiol II CalSet II<br>(K992981) | | Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Opened:<br>• 2-8°C: 24 hours<br>• 20-25°C: 5 hours on Elecsys<br>2010/cobas e 411; use only<br>once on MODULAR<br>ANALYTICS E170, cobas e<br>601 and cobas e 602<br>analyzers<br>• -20°C: 31 days (freeze only<br>once) | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Opened:<br>• 2-8°C: 24 hours<br>• 20-25°C: use only once<br>• -20°C: 3 month | | Traceability | The Elecsys Estradiol III CalSet was standardized against ID-GC/MS<br>(isotope dilution gas chromatography mass spectrometry). | | | Evaluations<br>Summary | The Elecsys Estradiol III CalSet was evaluated for value assignment,<br>reconstitution and stability. | | | CalSet Value<br>Assignment | Value assignment testing was conducted and passed pre-defined acceptance<br>criteria. The target values for the two levels of the Estradiol III CalSet kit are<br>chosen to obtain the best fit with the Master Calibration Curve, together with<br>the Rodbard curve parameters encoded in the reagent barcode. For each<br>Elecsys Estradiol III CalSet lot manufactured, the calibrators are run in<br>duplicate on at least three (3) Elecsys 2010/cobas e 411 analyzers and at least<br>three (3) cobas e 601/MODULAR ANALYTICS E170 analyzers with all<br>Estradiol III reagent lots available. The assigned value of each calibrator is<br>defined as the mean value obtained over at least six (6) runs on at least three (3)<br>analyzers) of the respective calibrator.<br>Measurement values for PreciControl Universal (Level 1 & 2), a multi-analyte<br>control recommended for use to monitor accuracy and precision of specified<br>analytes, are read from the calibration curves generated. The pre-defined<br>acceptance criteria for PreciControl Universal have to be met to release the<br>Assigned Values for Estradiol III CalSet. | | {3}------------------------------------------------ {4}------------------------------------------------ #### Stability Three studies were performed in order to verify the stability claims for the Studies Estradiol III CalSet. Stability studies after reconstitution and an accelerated stability study were completed on the cobas e 411. Additionally, a real-time stability study is planned. #### Study 1. Stability at 2-8ºC, -20ºC, in open vial and freeze/thaw cycles (after reconstitution): The on-test materials were reconstituted and stored closed for 73 hours at 2 to 8°C, and for 32 days at -20°C and for 7 hours at 20 to 25°C in open vial prior to testing. In addition, the stability of the Estradiol III CalSet for two (2) freeze/thaw cycles was evaluated. The on-test and reference materials were tested in duplicate and the recovery was calculated as percent of the reference value. The acceptance criterion was 95 to 105 % signal recovery of the reference material value. The reference material was a freshly reconstituted set of Estradiol III CalSet. #### Study 2. Accelerated Stability: The on-test material was stored lyophilized (as supplied to the user) at 35°C for 3 weeks. The reference material was a freshly reconstituted set of Estradiol III CalSet (stored at 2 to 8℃). After 3 weeks, the on-test and reference materials were tested in duplicate. The on-test recovery was calculated as a percent of the reference value. One Estradiol III CalSet lot was evaluated in duplicate. The acceptance criterion was 95 to 105 % recovery of the reference material value. {5}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Stability Studies, continued | <b>Study 3. Real-Time Stability:</b> <p>In addition, real-time stability is being evaluated as follows:</p> <p>In the on-going real-time stability study, the Estradiol III CalSet test material is stored at 2-8°C. The CalSets are tested in duplicate at specified intervals over the shelf life of the device up to the planned shelf life plus one month (19 months).</p> <p>Real-time stability is calculated based on the recovery of signal of stressed calibrator (stored at 2-8°C) vs. unstressed calibrator (stored at -20°C). At the specified intervals over the shelf life, the mean value of the stressed calibrator was calculated as percent recovery of the unstressed value (each tested in duplicates at the same time point).</p> <p>The acceptance criterion for Estradiol III Calibrator 1 and 2 is recovery of 95-105 % of the reference value.</p> <p>The testing will continue with this stability protocol until data to support a claim of 18 months are achieved.</p> | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | We trust that the information provided in this Premarket Notification (510(k)) will support a determination of substantial equivalence for the Elecsys Estradiol III CalSet. | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 29, 2014 ROCHE DIAGNOSTICS KELLI TURNER REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0416 Re: K142021 Trade/Device Name: Elecsys Estradiol III CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: July 24, 2014 Received: July 25, 2014 Dear Ms. Kelli Turner: This letter corrects our substantially equivalent letter of August 12, 2014. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 {7}------------------------------------------------ Page 2 - Ms. Kelli Turner medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Katherine Serrano -S For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) k 142021 Device Name Elecsys Estradiol III CalSet Indications for Use (Describe) Estradiol III CalSet is used for calibrating the quantitative Elecsys Estradiol III assay on the Elecsys and cobas e immunoassay analyzers. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) لــــــ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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