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.

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 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.

AI/ML Overview

This summary describes the Tosoh G7 Automated HPLC Analyzer in its HbA1c Variant Analysis Mode.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Tosoh A1c 2.2 Plus) by showing high correlation and precision. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device and satisfactory statistical results.

Metric	Implied Acceptance Criteria (via Predicate Comparison)	Reported Device Performance (G7 Automated HPLC Analyzer)
Comparative Analysis	Highly correlated with Tosoh A1c 2.2 Plus
Slope	Close to 1.0	1.001
Intercept	Close to 0.0	-0.12
Correlation Coefficient	Close to 1.0	0.9987
Range of Samples (%)	Comparable to predicate's operating range	3.4 - 15.9
Precision	Low %CVs
Intra-run precision %CVs	Not explicitly stated for predicate; generally low	0.9% or less
Inter-run precision %CVs	Not explicitly stated for predicate; generally low	1.6% or less
Total precision (mean 5.79% HbA1c)	Not explicitly stated for predicate; generally low	1.12%
Total precision (mean 10.90% HbA1c)	Not explicitly stated for predicate; generally low	0.71%
Recovery Studies	Close to 100%	100% to 102%

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 230 patient samples
Data Provenance: The document states "patient samples obtained from 230 patients." This implies clinical samples, likely from a patient population relevant to diabetes management. Given that the manufacturer is Tosoh Medics, Inc. based in South San Francisco, California, the data is likely from the United States, and it is almost certainly retrospective as samples were "obtained" and then assayed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus readings. Instead, the "ground truth" for the comparative analysis is implicitly the results obtained from the predicate device, the Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer. The study aims to show equivalence between the new device and the existing, cleared device, rather than establishing a completely independent ground truth.

4. Adjudication Method for the Test Set:

Not applicable. There was no expert "adjudication" in the traditional sense. The comparison was statistical against the predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for an automated in vitro diagnostic device, not an imaging device requiring human interpretation, so MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the study described is a standalone performance assessment of the G7 Automated HPLC Analyzer. It evaluates the device's analytical performance (comparative analysis, precision, recovery) in producing HbA1c results, without human interpretation of the chromatograms being the primary endpoint for clinical decision-making within the study design. The device is fully automated.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation was the results obtained from the predicate device (Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer). The study's objective was to demonstrate substantial equivalence to this already cleared device.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its sample size. For an IVD device like this, the development and training (calibration, algorithm optimization) would likely be an internal process before the equivalence study. The "230 patient samples" refer to the test set used for demonstrating substantial equivalence.

9. How the Ground Truth for the Training Set Was Established:

Not specified. As mentioned above, a separate training set is not explicitly detailed. The device likely uses internal calibration methods which would be established during development, rather than a "ground truth" for a machine learning training process described in the document. The device's operation relies on established HPLC principles and a "cation exchange column" with "three elution buffers." The software compares retention times to "known windows," implying pre-defined chemical properties rather than data-driven machine learning ground truth establishment.

Summary

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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:

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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.

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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 ofHb A1c and Total Hb A	Quantitative measurement ofHb A1c and Total Hb A
Methodology	HPLC	HPLC
Column	Non-porous cation exchange	Non-porous cation exchange
Reported result	Peak resolution:A1a, A1b, F, LA1c, SA1c, A0and variant (as P0X or H-VX))Percentage of SA1c and Total A1	Peak resolution:A1a, A1b, F, LA1c, SA1c. A0and variant (as HbS+)Percentage of SA1c and Total A1
Detection method	Visible wavelength detector415 nm (sample)500 nm (reference)	Visible wavelength detector415 nm (sample)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(undiluted or diluted)	Whole blood(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

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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.

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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.

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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

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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

Josephine Bautista

(Division Sign-Off) (Division of Clinical Laboratory Devices

510(k) Number

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and 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 (performance standards).