FERRITIN GENERATION 2

{0}------------------------------------------------ K03/650 # 510(k) Summary | Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 521 - 3544 | | | Contact Person: Kay A. Taylor | | | Date Prepared: May 27, 2003 | | Device Name | Proprietary name: Ferritin Generation 2 | | | Common name: Ferritin | | | Classification name: Ferritin, Antigen, Antiserum, Control | | Device<br>Description | A particle enhanced immunoturbidimetric assay in which human ferritin<br>agglutinates with latex particles coated with anti-ferritin antibodies. The<br>precipitate is determined turbidimetrically at 552 nm. | | Intended use | In vitro diagnostic reagent system intended for use on COBAS Integra system<br>for the quantitative immunological determination of human ferritin in serum<br>and plasma. | | Indications for<br>Use | Measurements of ferritin aid in the diagnosis of diseases affecting iron<br>metabolism such as hemochromatosis (iron overload) and iron deficiency<br>anemia. | | Substantial<br>Equivalence | The Ferritin Generation 2 is substantially equivalent to other devices legally<br>marketed in the United States. We claim equivalence to the COBAS Integra<br>Ferritin assay (K963292). Both products are intended for use in the<br>quantitative determination of Ferritin on automated clinical chemistry<br>analyzers. | : and the control of the comments of the control of {1}------------------------------------------------ ## 510(k) Summary, Continued Substantial equivalence similarities The following table compares the Ferritin Generation 2 Assay with the predicate device. | Feature | Ferritin Generation 2 | Ferritin<br>(predicate) | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | In vitro diagnostic reagent<br>system intended for use on<br>COBAS INTEGRA system<br>for the quantitative<br>immunological<br>determination of human<br>ferritin in serum and plasma. | In vitro diagnostic reagent<br>system intended for use on<br>COBAS INTEGRA system<br>for the quantitative<br>immunological determination<br>of human ferritin in serum<br>and plasma. | | Indication for Use | For the quantitative<br>determination of ferritin in<br>human serum and plasma.<br>Measurements of ferritin aid<br>in the diagnosis of diseases<br>affecting iron metabolism<br>such as hemochromatosis<br>(iron overload) and iron<br>deficiency anemia. | For the quantitative<br>determination of ferritin in<br>human serum and plasma.<br>Measurements of ferritin aid<br>in the diagnosis of diseases<br>affecting iron metabolism<br>such as hemochromatosis<br>(iron overload) and iron<br>deficiency anemia. | | Assay Protocol | Particle enhanced<br>Immunoturbidometric | Particle enhanced<br>Immunoturbidometric | | Instrument | COBAS Integra Clinical<br>Chemistry Analyzers | COBAS Integra Clinical<br>Chemistry Analyzers | | Sample Type | Serum and plasma | Serum and plasma | | Formulation | R: Glycine buffer stabilized<br>with 0.09% sodium azide,<br>5mg/ml rabbit globulin in<br>vial B (liquid).<br>R2: Latex particles coated<br>with anti-human ferritin<br>(rabbit) in glycine buffer,<br>stabilized with 0.09%<br>sodium azide in vial C<br>(liquid). | R: Glycine buffer stabilized<br>with 0.09% sodium azide in<br>vial B (liquid).<br>R2: Latex particles coated<br>with anti-human ferritin<br>(rabbit) in glycine buffer,<br>stabilized with 0.09% sodium<br>azide in vial C (liquid). | | Calibrator | FERR T Standard | FERR T Standard | | Controls | FERR /MYO T Control | FERR /MYO T Control | | Reagent Stability | On board: 12 weeks | On-board: 12 weeks | | Feature | Ferritin Generation 2 | Ferritin<br>(predicate) | | Expected Values | Females: 15-150 ng/ml<br>Males: 30-400 ng/ml<br>(3 mos-16 yrs):<br>20-200 ng/ml<br>(2nd-3rd month):<br>80-500 ng/ml<br>(1st month):<br>150-400 ng/ml<br>(umbilical cord blood):<br>50-250 ng/ml | Females: 10-120 ng/ml<br>Males: 20-300 ng/ml | | Measuring Range | 0-382 ng/ml | Integra 400: 0-280 ng/ml<br>Integra 700: 0-300 ng/ml | | Traceability /<br>Standardization | Standardized against the<br>NIBSC Reagents for Ferritin<br>(human spleen 80/578). | Traceable to WHO<br>Reference Preparation for<br>Human Liver Ferritin (1st<br>International Standard 1984) | | Calibration Interval | After each lot and 84 days | After each lot | 23 {2}------------------------------------------------ #### 510(k) Summary, Continued 1. 1. 1. 1. 1. Substantial equivalence differences The following table compares the Ferritin Generation 2 Assay with the predicate device. {3}------------------------------------------------ ## 510(k) Summary, Continued Substantial equivalence performance characteristics The performance characteristics of the Ferritin Generation 2 Assay and the predicate device are compared in the table below. | Feature | Ferritin Generation 2 | Apolipoprotein B<br>(predicate) | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Precision | Within run CV<br>9.0% @ 19.8 ng/ml<br>2.5% @ 107.5 ng/ml<br>Between Day CV<br>7.8% @ 20.3 ng/ml<br>3.4% @ 157.0 ng/ml | Within run CV<br>9.9% @ 19 ng/ml<br>1.2% @ 260 ng/ml<br>Between Day CV<br>10.2% @ 19 ng/ml<br>3.8% @ 260 ng/ml | | Method Comparison | Bablok/Passing:<br>Ferritin Generation 2 (Y) /<br>COBAS Integra Ferritin (X).<br>$y = 1.30x + 12.98$ ng/ml<br>$r = 0.922$ | Bablok/Passing:<br>Ferritin (Y)/<br>commercially available<br>system (X).<br>$y = 0.84x + 0.8$ ng/ml<br>$r = 0.992$ | | Limitations | • Icterus: No significant<br>interference<br>• Hemolysis: No<br>significant interference<br>up to a level 596 µmol/l.<br>• Lipemia: No significant<br>interference up to an<br>Intralipid level of 160<br>mg/dL<br>• Rheumatoid factors: No<br>significant interference | • Icterus: No significant<br>interference<br>• Hemolysis: No<br>significant<br>interference<br>• Lipemia: No<br>significant<br>interference<br>• Rheumatoid factors:<br>No significant<br>interference | | Prozone Effect | No effect up to 10,000 ng/ml | Integra 400/400 plus:<br>No effect up to 4300 ng/ml<br>Integra 700 /800:<br>No effect up to 45,000<br>ng/ml | | Analytical sensitivity<br>(LDL) | 7.5 ng/ml | 5 ng/ml | : {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird-like figure. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis. Indiana 46250-0457 JUL 17 2003 Re: k031650 Trade/Device Name: Roche COBAS Integra Ferritin Generation 2 Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF Dated: July 7, 2003 Received: July 9, 2003 Dear Ms. Taylor: 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. Drue, 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 (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. {5}------------------------------------------------ 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 (301) 594-3084. 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/dsma/dsmamain.html. Sincerely yours, Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Indications for Use Statement 510(k) Number (if known): N/A Device Name: Ferritin Generation 2 Test System Indications For Use: In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia. Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) J. Reeve for J. Bautista Division Sign-Off **Division Sign-Off** ice of In Vitro Diagnostic Evaluation and 510(k) K031650 20