The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for IN VITRO DIAGNOSTIC USE for the measurement of hemoglobin A1c (HbA1c) in whole blood specimens. Hemoglobin A1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.

The Hemoglobin A1c Calibrator Set is a reference agent designed for calibrating the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.

Device Description

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (G8) is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable Alc (sAlc) percentage in whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors. sample loader, floppy disk drive unit, operation panel, and a printer.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses non-porous ionexchange high performance liquid chromatography (HPLC) for rapid, accurate and precise separation of the stable form of HbA1c from other hemoglobin fractions. The G8 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, Ala, A1b, F, L-A1c, sA1c, and A0. The separation is done by eluting the hemoglobins from the column with a stepwise elution of three elution buffers containing different salt concentrations. The result report is printed out and can be stored on a digital media. 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 calibrator set consists of two levels of calibrator, the low level in the non-diabetic range and the high level in the diabetic range. These two calibrators are used to establish a reference curve from which to establish the percentage of HbA1c in patient and control samples.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Difference between device and predicate to be within allowable error range	100% of 114 specimens (HbA1c range 4.0-16.8%) showed differences within ±0.5% compared to the predicate device.
Functioning as intended, with expected A1c and Total HbA measurements	"In all instances, the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set functioned as intended and measurement of A1c and Total HbA was as expected."

Note: The document does not explicitly state numerical acceptance criteria for precision, linearity, or other specific performance aspects beyond the method comparison. The "allowable error range" for the method comparison is defined as ±0.5%.

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

Sample Size: 114 specimens
Data Provenance: Not explicitly stated (e.g., country of origin). The study compared the new device against a predicate device. It is presented as a singular comparison study to demonstrate substantial equivalence, implying it was a retrospective analysis of samples rather than a prospective trial with new patients.

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

Not applicable. The "ground truth" for the test set was established by the predicate device's measurements, not by expert consensus. The study focused on comparing the new device's measurements against these established values.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of an adjudication process as the comparison was made against a single predicate device's output.

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

No, an MRMC comparative effectiveness study was not done. The study detailed is a method comparison study between a new automated analyzer and a predicate automated analyzer, not an evaluation of human readers with or without AI assistance.

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

Yes, a standalone performance study was done. The entire study describes the performance of the automated analyzer (algorithm/instrument only) in measuring HbA1c, without any human intervention in the measurement process beyond sample loading.

7. The Type of Ground Truth Used

The ground truth used for the method comparison was the measurements obtained from the predicate device, Tosoh Bioscience, Inc.'s G7 Automated HPLC Analyzer (K011434).

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. This is typical for a device like an automated analyzer, where performance is validated through analytical studies (precision, linearity, method comparison) rather than machine learning model training. The calibrators are used for establishing the reference curve within the device's operational setup, but this isn't a "training set" in the context of AI/ML.

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

Not applicable, as a "training set" in the AI/ML sense is not described. For the instrument's operation, the "ground truth" (or reference) for its internal calibration is established using a two-level Hemoglobin A1c Calibrator Set, with the low level in the non-diabetic range and the high level in the diabetic range. These calibrators establish a reference curve for the instrument.

Summary

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K07/132

SEP 1 6 2008

510(k) SUMMARY

Tosoh Bioscience, Inc.'s Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set

Submitter's Name, Address, Telephone Number, and Date Prepared

Tosoh Bioscience, Inc. 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080

Phone: (800) 248-6764 Facsimile: (650) 615-0415 Date Prepared: April 24, 2008

Contact Person:

Charles Gill Manager, Regulatory Affairs/Quality Assurance Tosoh Bioscience, Inc. 3600 Gantz Road Grove City, OH 43123 Phone: (614) 317-1909

Name of Device and Name/Address of Sponsor

Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set Tosoh Bioscience, Inc. 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 Phone: (800) 248-6764 (650) 615-0415 Fax:

Common or Usual Name

Glycosylated Hemoglobin Assay

Classification Name

Assay, Glycosylated Hemoglobin Calibrator, Primary

Regulation and Product Code

21 C.F.R. § 864.7470, LCP 21 C.F.R. § 862.1150, JIS

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Predicate Device

Tosoh Bioscience, Inc.'s G7 Automated HPLC Analyzer (K011434)

Intended Use / Indications for Use

The Hemoglobin A1c Calibrator Set is a reference agent designed for calibrating the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.

Technological Characteristics

Performance Data

Tosoh Bioscience, Inc., has conducted substantial performance testing on the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set, including interference testing, variant interference testing, method comparison testing with the predicate, dilution (total area/linearity), recovery/linearity testing, intra- and inter-assay precision testing, total precision/reproducibility testing, traceability, and analytic

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specificity testing. In addition, Tosoh Bioscience, Inc., compared the performance of the the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin Alc Calibrator Set to its predicate device. A total of 114 specimens over a range of 4.0 to 16.8 % were compared. The difference between the two devices was within the allowable error range for all 114 of 114 specimens (100% ± 0.5). In all instances, the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set functioned as intended and measurement of A1c and Total HbA was as expected.

Substantial Equivalence

The Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set is as safe and effective as the predicate device. The Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin Alc Calibrator Set is as safe and effective as the predicate device. Thus, the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 6 2008

Tosoh Bioscience, Inc. c/o Mr. Charles P. Gill Manage, Regulatory Affairs/Quality Assurance 6000 Shoreline Court, Ste. 101 South San Francisco, CA 94080

Re: K071132

Trade/Device Name: Automated Glycohemoglobin Analyzer HLC-723G8 Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP, JIS Dated: August 25, 2008 Received: August 25, 2008

Dear Mr. Gill:

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, Drug, 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).

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Page 2 -

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.

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 (240) 276-0490. 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 mumber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indication For Use:

K071132

G8 Automated Glycohemoglobin Analyzer HLC-723G8

The G8 Automated Glycohemoglobin Analyzer

HLC-723G8 is intended for IN VITRO DIAGNOSTIC USE for the measurement of hemoglobin A1c (HbA1c) in whole blood specimens. A1c measurements are used in the clinical management of diabetes to assess the longterm efficacy of diabetic control.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Chappie Inin

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

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Indications for Use

K071132

510(k) Number (if known):

Device Name:

Hemoglobin A1C Calibrator Set

Indication For Use:

The A1C Calibrator Set is a reference agent designed for calibrating Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.

Prescription Use __ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ann Chappe
Division Sign-Off

Office of In Vitre Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

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).