SEP I 62008

510(k) SUMMARY

Tosoh Bioscience, Inc.'s

Automated Glycohemoglobin Analyzer HLC-723G8 and
Hemoglobin Ale 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 AI c Calibrator Set

Tosoh Bioscience, Inc.
6000 Shoreline Ct., Ste. 101
South San Francisco, CA 94080
Phone: (800) 248-6764
Fax: (650) 615-0415

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
Predicate Device

Tosoh Bioscience, Inc.'s G7 Automated HPLC Analyzer (KOl 1434)

Intended Use / Indications for Use

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for IN

VITRO DIAGNOSTIC USE for the measurement of hemoglobin AI c (HbA1 c) in whole
blood specimens. Hemoglobin Al c measurements are used in the clinical management
of diabetes to assess the long-term efficacy of diabetic control.

The Hemoglobin Al c 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 A1c (sAIc) 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 ion-

exchange high performance liquid chromatography (HPLC) for rapid, accurate and
precise separation of the stable form of HbAlc from other hemoglobin fractions. The G8
uses a cation exchange column and separates the usual hemoglobin components in the
blood into six fractions, Ala, Alb, F, L-Alc, sAIc, and AO. 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, sA Ic percentage and total Al percentage (Ala + A lb + sA Ic),
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 HbA 1c in patient and control
samples.

Performance Data

Tosoh Bioscience, Inc., has conducted substantial performance testing on the Automated
Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin Al c 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
 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 Al c Calibrator Set functioned
as intended and measurement of AI c and Total HbA was as expected.

Substantial Equivalence

The Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin AI c

Calibrator Set is as safe and effective as the predicate device. The Automated
Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin Alc 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 AI c 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 Al c Calibrator Set is as safe and effective as the predicate device. Thus, the
Automated Glycohemoglobin Analyzer HLC-723 G8 and Hemoglobin Al c Calibrator Set
is substantially equivalent.
 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

2098 Gaither Road
Rockville MD 20850
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).
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 number
(800) 638-2041 or (240) 276-3150 or at its Internet address at
http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

J an 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
 Indications for Use

510(k) Number (if known): K071132

Device Name: G8 Automated Glycohemoglobin

Analyzer HLC-723G8

Indication For Use: The G8 Automated Glycohemoglobin Analyzer

HLC-723G8 is intended for INVITRO DIAGNOSTIC
USE for the measurement of hemoglobin Al c (HbAl c) in
whole blood specimens. Alc measurements are used in
the clinical management of diabetes to assess the long-
term 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 InVitro Diagnostic Device Evaluation and Safety

(OIVD)
Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safty
 Indications for Use

510(k) Number (if known): K071132

Device Name: Hemoglobin A1C Calibrator Set

Indication For Use: The AlC 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 InVitro Diagnostic Device Evaluation and Safety

(OIVD) 0

Division Sign-Off -

Office of In Vitt-' Diagnostic Device

Evaluation and g3tety
5 YO(k) ___, _ ________?_