INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

{0}------------------------------------------------ SEP 3 0 1999 ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺭﻳﺪ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ K990992 # 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<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>(317) 576-3723 | | | Contact person: Priscilla A. Hamill | | | Date prepared: September 28, 1999 | | Device name | Proprietary name: INTEGRA Reagent Cassette for Hemoglobin A1c | | | Common name: Hemoglobin A1c | | | Classification name: Glycosylated Hemoglobin Assay | | Predicate<br>device | The INTEGRA Reagent Cassette for Hemoglobin A1c is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche INTEGRA Reagent Cassette for Hemoglobin A1c (K961824) | | Device<br>description | The device is an immunoturbidimetric test for the quantitative determination of per cent Hemoglobin A1c in anticoagulated venous or capillary whole blood for use on the INTEGRA family of analyzers. | | | Continued on next page | {1}------------------------------------------------ · | Intended use | For in vitro quantitative determination Hemoglobin A1c in anticoagulated<br>whole blood. | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial<br>equivalence --<br>similarities | The INTEGRA Reagent Cassette for Hemoglobin A1c is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably, it is substantially equivalent to the currently marketed<br>Roche INTEGRA Reagent Cassette for Hemoglobin A1c (K961824). | | | The following table illustrates the similarities between the modified<br>INTEGRA Reagent Cassette for Hemoglobin A1c and the predicate device.<br>Draft labeling is included in Section V of this submission. Labeling for the<br>predicate device is provided in Section VI. | | | Continued on next page | {2}------------------------------------------------ | Feature | Modified Device (Roche<br>INTEGRA Cassette for<br>Hemoglobin A1c Whole<br>Blood Application) | Modified Device (Roche<br>INTEGRA Cassette for<br>Hemoglobin A1c Hemolysate<br>Application) | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | For the quantitative<br>determination of Hemoglobin<br>A1c. | For the quantitative<br>determination of Hemoglobin<br>A1c. | | Indications<br>for use | For monitoring of long term<br>blood glucose control in<br>individuals with diabetes<br>mellitus. | For monitoring of long term<br>blood glucose control in<br>individuals with diabetes<br>mellitus. | | Methodology | Immunoturbidimetric test<br>for HbA1c Colorimetric test for Total<br>Hb | Immunoturbidimetric test<br>for HbA1c Colorimetric test for Total<br>Hb | | Measure-<br>ment<br>approach | Spectrophotometric | Spectrophotometric | | Instrument<br>required | INTEGRA family of analyzers | INTEGRA family of analyzers | | Measuring<br>range | Hb: 81-644 mg/dL HbA1c: range depends on<br>value of HbA1c calibrator;<br>a typical range is 1.3-41.9<br>mg/dL For a typical value of Hb<br>of 13.2 g/dL, the test range<br>for the final HbA1c(%)<br>results is 3-31% | Hb: 81-644 mg/dL HbA1c: range depends on<br>value of HbA1c calibrator;<br>a typical range is 1.3-41.9<br>mg/dL For a typical value of Hb of<br>13.2 g/dL, the test range for<br>the final HbA1c(%) results<br>is 3-31% | | Sample type | Anticoagulated venous or<br>capillary blood | Anticoagulated venous or<br>capillary blood | Continued on next page {3}------------------------------------------------ Substantial equivalence -differences The primary difference between the modified device and the predicate device is that the preparation of hemolysate is automated on the INTEGRA analyzer. Minor modifications in formulation and application parameters have also been made. The following table illustrates the differences between the INTEGRA Reagent Cassette for Hemoglobin A1c and the predicate device. | Feature | Modified Device (Roche<br>INTEGRA Cassette for<br>Hemoglobin A1c Whole Blood<br>Application) | Modified Device (Roche<br>INTEGRA Cassette for<br>Hemoglobin A1c<br>Hemolysate Application) | |------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Sample<br>preparation | Automated preparation of<br>hemolysate from anticoagulated<br>venous or capillary blood | Manual preparation of<br>hemolysate from<br>anticoagulated venous or<br>capillary blood | | Reagent<br>Formulation | Modification in component<br>concentrations. | Latex coated with mouse<br>MAB for HbA1c Buffer, pH 11.5 BSA Formate Agglutinator | | Hemolyzing<br>reagent | 80 mmol/L citric acid pepsin >1500 kU/L | 20 mmol/L citric acid pepsin >100kU/L | | Wavelength | Hb - 552/659 HbA1c - 552 nm | Hb - 552/659 HbA1c - 552 nm | Continued on next page {4}------------------------------------------------ Substantial equivalence -performance characteristics Performance characteristics of the two devices are equivalent. | Feature | Modified Device (Roche<br>INTEGRA Cassette for<br>Hemoglobin A1c Whole Blood<br>Application) | Modified Device (Roche<br>INTEGRA Cassette for<br>Hemoglobin A1c Hemolysate<br>Application) | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Precision | Within-run CV<br>2.3% at 4.7%<br>2.2% at 10.3%<br>Total CV<br>2.4% at 4.7%<br>2.4% at 10.3% | Within-run CV<br>1.5% at 4.8%<br>1.8% at 12.1%<br>Total CV<br>2.8% at 4.8%<br>2.4% at 12.1% | | Analytical<br>sensitivity | Hb: 1.5 mg/dL<br>HbA1c: 0.4 mg/dL | Hb: 1.5 mg/dL<br>HbA1c: 0.4 mg/dL | | Interfering<br>substances | No significant interference from<br>unconjugated bilirubin (60 mg/dL),<br>lipemia (2000 mg/dL), or glycemia<br>(1000 mg/dL), acetylated Hb,<br>carbamylated Hb, and labile<br>HbA1c. | No significant interference<br>from icterus (25 mg/dL),<br>lipemia (2000 mg/dL), or<br>glycemia (1000 mg/dL),<br>acetylated Hb, carbamylated<br>Hb, and labile HbA1c. | | Calibration<br>stability | Each lot and every 57 days | Each lot and every 43 days | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. #### SEP 3 0 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Priscilla Hamill Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 K990992 Re: Trade Name: INTEGRA Reagent Cassette for Hemoglobin A1c Regulatory Class: II Product Code: LCP Dated: July 30, 1999 Received: August 2, 1999 Dear Ms. Hamill: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {6}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # 510(k) Number (if known): Device Name: INTEGRA Reagent Cassette for Hemoglobin Alc Indications for Use: For the quantitative determination of Hemoglobin A 1c in anticoagulated whole blood. Hemoglobin A I c is indicated for the monitoring of long term blood glucose control in individuals with diabetes mellitus. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) (PLEASE DO NOT WINTE BEBO # THIS LANS-----------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use _ (Optional format 1-2-96) Peter E. Martini (Division Sign-Off) Division of Clinical Laboratory Devices K990992 510(k) Number