G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8

K071132 · Tosoh Bioscience, Inc. · LCP · Sep 16, 2008 · Hematology

Device Facts

• Record ID: K071132
• Device Name: G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
• Applicant: Tosoh Bioscience, Inc.
• Product Code: LCP · Hematology
• Decision Date: Sep 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

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 Story

Automated HPLC system; processes EDTA whole blood samples; separates hemoglobin components (A1a, A1b, F, L-A1c, sA1c, A0) via cation exchange column and gradient elution with three salt-concentration buffers; utilizes microprocessors for automated analysis; outputs stable A1c (sA1c) percentage. Used in clinical laboratory settings; operated by trained personnel. Provides quantitative HbA1c results to clinicians for diabetes management and glycemic control assessment. System includes sampling unit, liquid pump, degasser, detector, sample loader, and printer.

Clinical Evidence

Bench testing only. Precision evaluated via within-run and between-run studies (n=20 replicates per sample); %CV ranged from 0.39% to 1.30%. Linearity verified across 4.0%–16.9% HbA1c range with recoveries within ±5%. Method comparison against predicate (n=114) showed slope 1.020, y-intercept -0.16, r=0.998. Interference studies confirmed no significant impact from labile A1c, icterus, lipemia, or common medications. Reference range established using 146 healthy adults (4.4%–6.1% HbA1c).

Technological Characteristics

Automated ion-exchange HPLC system. Components: sampling unit, liquid pump, degasser, cation exchange column, detector, microprocessors, sample loader, floppy drive, operation panel, printer. Uses stepwise elution with three salt-concentration buffers. Connectivity: digital media storage, printer output.

Indications for Use

Indicated for use in clinical management of diabetes to assess long-term efficacy of diabetic control in patients requiring HbA1c monitoring. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• Tosoh G7 Automated HPLC Analyzer (k011434)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone] 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: [phone]

#### 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: [phone] [phone] 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 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.

## Technological Characteristics

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.

## 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 [phone]. 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 [phone] or [phone] 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)________________________________________________________________________________________________________________________________________________________________________