SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT

{0}------------------------------------------------ K973696 Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Summary of Safety & Effectiveness NOV ## Summary of Safety & Effectiveness Beckman SYNCHRON® Systems Hemoglobin A1c Reagent #### 1.0 Submitted Bv: Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457 #### 2.0 Date Submitted: 24 September 1997 #### 3.0 Device Name(s): ## 3.1 Proprietary Names SYNCHRON® Systems Hemoglobin A1c (HbA1c) Reagent #### 3.2 Classification Name Glycosylated hemoglobin assay (21 CFR § 864.7470) #### 4.0 Predicate Device(s): | BECKMAN Reagent | Predicate | Predicate Company | Docket Number | |------------------------------------|----------------------------------------|------------------------------------|---------------| | SYNCHRON Systems<br>Hemoglobin A1c | Tina-quant®<br>Hemoglobin A1c<br>Assay | Boehringer Mannheim<br>Corporation | K934070 | #### 5.0 Description: The SYNCHRON Hemoglobin A1c (HbA1c) Reagent kit contains two reagents, Hb and A1c for determining the Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems. #### 6.0 Intended Use: The SYNCHRON Hemoglobin A1c (HbA1c) Reagent kit, in conjunction with the SYNCHRON Hemoglobin A1c Calibrators, is intended for the quantitative determination of hemoglobin A1c concentration as a percentage of total hemoglobin in whole blood on SYNCHRON Systems. #### 7.0 Comparison to Predicate(s): The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary. {1}------------------------------------------------ Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Summary of Safety & Effectiveness | Reagent | Aspect/Characteristic | Comments | |-------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------| | | SIMILARITIES | | | SYNCHRON<br>Systems Hemoglobin<br>A1c<br>(HbA1c)<br>Reagent | Intended use | Same as the predicate | | | Formulation | Same source, processing as predicate | | | Chemical Reaction | Same principle as the predicate | | | Sample Preparation | Same as the predicate | | | Calibration | Same as the predicate | | | Reagent Kit Configuration | Same as the predicate | | | DIFFERENCES | | | SYNCHRON Systems<br>Hemoglobin A1c<br>(HbA1c)<br>Reagent | Assay parameters | SYNCHRON parameters reside in the<br>SYNCHRON database, BMC<br>parameters must be operator<br>programmed | | | Cartridges | Cartridges bar-coded specifically for<br>SYNCHRON HbA1c vs non bar-coded<br>cartridges with BMC reagent | #### Summary of Performance Data: 8.0 . The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that relate results obtained from the SYNCHRON HbA1c Reagent to the Boehringer Mannheim Tina-quant® Hemoglobin A1c assay. ### Method Companison Study Results | Analyte | Slope | Intercept | r | Predicate Method | |--------------------------------------------------|--------|-----------|--------|---------------------------------------------------------------------------| | SYNCHRON<br>Hemoglobin A1c<br>(HbA1c)<br>Reagent | 0.9906 | -0.19% | 0.9698 | Boehringer Mannheim<br>Hemoglobin A1c Reagent on<br>SYNCHRON CX4CE System | | Reagent | 0.9937 | -0.25% | 0.9678 | Biorad DiamatTM HPLC<br>Hemoglobin A1c Method | ### Stability Study Results | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>ANNUAL AND COLORIAL COLLEGIAN<br>-------------------------------------- | 1 100 11 11 15 15 15 15 15 15 15 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11<br>RECENTRAL II LANDARIES OF LEASTER CONSULTION OF<br>AND CORPARA CORPORATION OF COLLECTION OF | | Comments of the contraction of the contribution of the commend of the commend of the commend of the many of the many of the many of the many of the many of the many of the ma<br><br>.<br> | <br>11 18 1 1 8 8 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | ### Estimated SYNCHRON HbA1c Reagent Imprecision | Sample | Mean (%HbA1c) | S.D. (%) | %C.V. | N | |------------------------|---------------|----------|-------|----| | Within-Run Imprecision | | | | | | Level 1 | 6.05 | 0.27 | 4.5 | 80 | | Level 2 | 8.75 | 0.26 | 3.0 | 80 | | Level 3 | 10.73 | 0.31 | 2.9 | 80 | | Total Imprecision | | | | | | Level 1 | 6.05 | 0.44 | 7.2 | 80 | | Level 2 | 8.75 | 0.52 | 6.0 | 80 | | Level 3 | 10.73 | 0.74 | 6.9 | 80 | The Summary of Safety and Effectiveness information for the SYNCHRON Systems HbA1c Reagents are found in TAB 1 of this notice and are being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and implementing regulation 21 CFR 807.92. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight. The logo is presented in black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 2 4 1997 Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 800 Brea, California 92822-8000 Re: K973696 Synchron® Systems Hemoglobin A1c (HbA1c) Reagent Regulatory Class :... II . .............................. Product Code: LCP September 24, 1997 Dated: Received: September 26, 1997 Dear Ms. Stockert: 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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (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 In addition, FDA may publish further announcements action. 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 requlations. {3}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHIA-68), Chila device may require 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 Inis leccer will aremarket notification. The FDA described in your sio\n privalence of your device to a legally marketed predicate device results in a classification for your marketed produces 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 Victo diagnoBele develop, productionally, 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 Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathed from onember (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Steven Gutman 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 {4}------------------------------------------------ K973696 of 510(k) Number (if known): Not yet assigned ### SYNCHRON® Systems Hemoglobin A1c Reagent Device Name: Indications for Use: The SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Kit, in conjunction with SYNCHRON HbA1c Calibrators and SYNCHRON HbA1c Hemolyzing Reagent, is intended for the quantitative determination of Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems. # 21 CFR 864.7470 Glycosylated hemoglobin assay (a) Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. (b) Classification. Class II. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices | 510(k) Number | 2973696 | |---------------|---------| |---------------|---------| | Prescription Use (per 21 CFR 801.109) | Over-the-Counter Use Optional Format 1-2-96 | |---------------------------------------|---------------------------------------------| |---------------------------------------|---------------------------------------------|