G7 AUTOMATED HPLC ANALYZER

{0}------------------------------------------------ KD11434 SEP 1 8 2001 ### 510(k) Summary ### Tosoh G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode Submitter: Tosoh Medics, Inc. 347 Oyster Point Blvd., Suite 201 South San Francisco, CA 94080 Phone: (800) 248-6764 Fax: Contact Person: Lois Nakayama Manager, Quality Assurance Date of Summary Preparation: Device Name: Classification Name: Predicate Device: August 23, 2001 G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode Class II, LCP 21 CFR 864.7470 Glycosylated Hemoglobin Assay A1c 2.2 Plus Automated Glycohemoglobin Analyzer Tosoh Medics, Inc. South San Francisco, CA K972265 #### Device Description: The G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A1c (SA1c) percentage in whole blood. The operational portion of the HPLC G7 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer. The G7 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A1a, A1b, F, L-A1c, SA1c and A0. The separation is done by eluting the hemoglobins from the column with a gradient of three elution buffers containing different salt concentrations. The result report is printed out from the on-board printer and can be stored on a floppy disk from the on-board floppy disk drive. The data can be transmitted to a host computer. The result report includes a sample ID, date, percentage and retention time of each fraction, SA1c percentage and total A1 percentage (A1a + A1b + SA1c) along with a chromatogram of the elution {1}------------------------------------------------ pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge. The software compares the retention times to "known windows" and designates the material as P0X or H-VX if it does not match a defined window. All automated processes in the G7 are controlled by internal microprocessors, using software downloaded via the on-board floppy disk drive. #### Statement of Intended Use: The G7 Automated HPLC Analyzer - HbA1c Variant Analysis Mode is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated hemoglobin measurements obtained by this device are used in the management and treatment of diabetes. #### Substantial Equivalence: #### Comparison Data: The G7 Automated HPLC Analyzer - HbA1c Variant Analysis Mode is substantially equivalent in intended use and technological features to instrument systems in commercial distribution, that are used to measure the glycohemoglobin level in the blood by HPLC methodology. Specifically, the G7 Automated HPLC Analyzer – HbA1c Variant Analysis Mode is substantially equivalent to the Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer (see K972265) which has been reviewed and cleared to market by FDA. A comparison of the capabilities and specifications of these two systems is provided in Table 1. Pertinent similarities and differences between the analyzers are presented in detail below. {2}------------------------------------------------ ### Table 1 # G7 Automated HPLC vs. A1c 2.2 Plus Comparison | | G7 - Hb A1c Variant Analysis Mode | A1c 2.2 Plus | |-------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Intended Use | Quantitative measurement of<br>Hb A1c and Total Hb A | Quantitative measurement of<br>Hb A1c and Total Hb A | | Methodology | HPLC | HPLC | | Column | Non-porous cation exchange | Non-porous cation exchange | | Reported result | Peak resolution:<br>A1a, A1b, F, LA1c, SA1c, A0<br>and variant (as P0X or H-VX))<br>Percentage of SA1c and Total A1 | Peak resolution:<br>A1a, A1b, F, LA1c, SA1c. A0<br>and variant (as HbS+)<br>Percentage of SA1c and Total A1 | | Detection method | Visible wavelength detector<br>415 nm (sample)<br>500 nm (reference) | Visible wavelength detector<br>415 nm (sample)<br>500 nm (reference) | | Microprocessor | Yes | Yes | | User Input | Pressure sensitive LCD | Pressure sensitive LCD | | Visual display | LCD display | LCD display | | Throughput | 2.2 minutes per sample | 3.0 minutes per sample | | Automated | Yes | Yes | | Calibration | 2 point | 2 point | | Sample type | Whole blood<br>(undiluted or diluted) | Whole blood<br>(undiluted or diluted) | | Sample volume | 3 uL | 5 uL | | Auto Dilution | Yes | Yes | | Sample loading capacity | 90 or 290 (automatic) | 50 or 90 or 290 (automatic) | | Sample holder | Primary tube or Sample cup | Primary tube or Sample cup | | Printer | Thermal | Thermal | | Bar-Code Capability | Yes | Yes | | RS-232C | Yes, Bi-directional | Yes, Uni-directional | {3}------------------------------------------------ #### Comparative Analysis Comparative analysis studies were performed with patient samples obtained from 230 patients by assaying the samples with the G7 Automated HPLC Analyzer in the HbA1c Variant Mode and the A1c 2.2 Plus Automated Glycohemoglobin Analyzer. Least squares linear regression analysis yields the following statistics: Comparative Analysis: G7 Automated HPLC vs. A1c 2.2 Plus | Slope: | 1.001 | |--------------------------|------------| | Intercept: | -0.12 | | Correlation Coefficient: | 0.9987 | | Range of Samples (%): | 3.4 - 15.9 | | Number of Samples: | 230 | Precision studies demonstrated intra-run precision %CVs of 0.9% or less and inter-run precision %CVs of 1.6% or less. Total precision at a HbA1c mean of 5.79% was 1.12% while at a mean value of HbA1c of 10.90%, the total precision was 0.71%. Recovery studies performed with samples mixed in specified ratios generated recoveries of 100% to 102%. #### Conclusion: Considering the excellent correlation between the Tosoh G7 Automated HPLC - HbA1c Variant Analysis Mode and the A1c 2.2 Plus, it can be concluded that the G7 Automated HPLC Analyzer -HbA1c Variant Analysis Mode is substantially equivalent to the A1c 2.2 Plus Automated Glycohemoglobin Analyzer, which has been 510(k) cleared. Based on the establishment of substantial equivalence, the safety and effectiveness of the Tosoh G7 HPLC is confirmed. {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 consists of a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ## SEP 1 8 2001 Ms. Lois Nakayama TOSOH Medics, Inc. 347 Oyster Point Boulevard Suite 201 South San Francisco, California 94080 Re: K011434 Trade Name: G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode Regulation Number: 21 CFR § 864.7470 Regulatory Class: II Product Code: LCP Dated: July 13, 2001 Received: July 19, 2001 Dear Ms. Nakayama: 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. {5}------------------------------------------------ #### Page 2 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlv/dsma/dsmamain.html". Sincerely yours. Steven Putman 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a stylized four-petal flower shape with a square in the center, followed by the text "TOSOH MEDICS, INC." to the right. Below the flower shape, the text "TOSOH" is printed in a smaller font size. ### PREMARKET NOTIFICATION ### INDICATION FOR USE STATEMENT # G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode The G7 Automated HPLC Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated system intended for wents obtained by this device are used in the management and treatment of diabetes. Josephine Bautista (Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number