SENTINEL CERULOPLASMIN

{0}------------------------------------------------ ## OCT 2 1 2005 # 510(k) Summary Submitter's Name/Address Sentinel CH. S.r.l. via Principe Eugenio, 5 20155 Milan, Italy Contact Person Davide Spada Application Specialist +39 02 345514.1 Fax +39 02 345514.64 | Date of Preparation of this Summary: | August 30, 2005 | |--------------------------------------------------|------------------------| | Device Trade or Proprietary Name: | Sentinel Ceruloplasmin | | Device Common/Usual Name or Classification Name: | ceruloplasmin | | Classification Number/Class: | JFR/Class II | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ #### Test Description: Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample. #### Substantial Equivalence: The Sentinel Ceruloplasmin assay is substantially equivalent to the Roche Ceruloplasmin assay (which was exempted from the Premarket Notification) on the Roche/Hitachi 911 Analyzer (Previously named Boehringer Mannheim Hitachi 911 Analyzer, K921661). These assays yield similar Performance Characteristics. Page 2 of 4 {1}------------------------------------------------ #### Similarities: - Both assays are in vitro clinical chemistry methods. . - Both assays can be used for the quantitative determination of analyte name. . - Both assays yield similar clinical results. . - Both assays have the same reference range. . #### Differences: There is a difference between the assay ranges. #### Intended Use: The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin in serum or plasma. #### Performance Characteristics: Comparative performance studies were conducted using the AEROSET® System. The Sentinel Ceruloplasmin assay method comparison yielded acceptable correlation with the Roche Ceruloplasmin assay on the Roche/Hitachi 911 Analyzer. The Passing & Bablok regression was: slope = 1.0256, and Y-intercept = -1.0205 mg/dL. Precision studies were conducted using the Sentinel Ceruloplasmin assay. Within-run and between-run studies were performed using three levels of control material. The total %CV for Level 1 is 3.69%, Level 2 is 5.33%, and Level 3 is 4.53%. The Sentinel Ceruloplasmin assay is linear up to 110 mg/dL. The limit of quantititation (sensitivity) of the Sentinel Ceruloplasmin assay is 2 mg/dL. These data demonstrate that the performance of the Sentinel Ceruloplasmin assay is substantially equivalent to the performance of the Roche Ceruloplasmin assay on the Roche/Hitachi 911 (Previously named Boehringer Mannheim Hitachi 911 Analyzer, K921661). S {2}------------------------------------------------ ### Conclusion: The Sentinel Ceruloplasmin assay is substantially equivalent to the Roche Ceruloplsmin assay on the Roche/Hitachi 911 Analyzer as demonstrated by results obtained in the studies. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Sentinel CH. S.r.l. c/o Mr. Davide Spada Application Specialist Via Principe Eugenio, 5 20155 Milano, Italy OCT 2 1 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Re: k051456 Trade/Device Name: Sentinel Ceruloplasmin Regulation Number: 21 CFR 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: Class II Product Code: JFR Dated: May 28, 2005 Received: June 2, 2005 Dear Mr. Spada: 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 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 Part 801); 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. 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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. {4}------------------------------------------------ Page 2 – 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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely yours, Robert Beckerh Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): 长 0514576 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder. Prescription Use _ X (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 In Vitro Diagnostic Devices (OIVD) Marie Chan Division Sign-Off Office of In Vitro Diagne Device Evaluation and So 510(k) ko51456 Page 1 of ____________________________________________________________________________________________________________________________________________________________________