A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER by TOSOH MEDICS, INC.

The A1c 2.2 Plus Automated Glycohemoglobin Analyzer 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.

Device Description

The A1c 2.2 Plus Automated Glycohemoglobin Analyzer is a high pressure liquid chromatography system.

AI/ML Overview

The provided document is a 510(k) premarket notification approval letter for the A1c 2.2 Plus Automated Glycohemoglobin Analyzer. This device is an in vitro diagnostic (IVD) device used for measuring glycosylated hemoglobin in the management and treatment of diabetes.

The document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as it pertains to a study proving the device meets acceptance criteria. The letter is an FDA approval, stating that the device is substantially equivalent to legally marketed predicate devices, and grants permission to market the device. It does not include the specifics of the performance studies themselves, which would typically be found in the 510(k) summary or full submission.

Therefore, I cannot provide the requested information based on the given text.

To be clear:

A table of acceptance criteria and the reported device performance: Not present in the provided document.
Sample sized used for the test set and the data provenance: Not present.
Number of experts used to establish the ground truth for the test set and the qualifications: Not present.
Adjudication method for the test set: Not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an automated analyzer, not an AI-assisted diagnostic tool requiring human reader involvement.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is described as an "Automated Glycohemoglobin Analyzer," implying a standalone, automated performance. However, details of the study are not provided.
The type of ground truth used: Not explicitly stated, but for a device measuring glycosylated hemoglobin, the ground truth would typically be reference methods of glycosylated hemoglobin measurement, or clinical outcome data. Details are not in the provided text.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 25

Lori Robinson Manager, Quality Assurance Tosoh Medics, Inc. 373 D Vintage Park Drive 94404 Foster City, California

K972265 Re : A1c 2.2 Plus Automated Glycohemoglobin Analyzer Requlatory Class: II Product Code: LCP Dated: August 27, 1997 Received: August 28, 1997

Dear Ms. Robinson:

requlations.

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 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 The general controls provisions of the Act 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 requlations 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 In addition, FDA may publish further announcements action. 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

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Ditman

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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TOSOH MEDICS, INC.

PREMARKET NOTIFICATION

INDICATION FOR USE STATEMENT

A1c 2.2 Plus Automated Glycohemoglobin Analyzer

iPlease do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Carol Benson Alfred Montgomery
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K-972265

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

0015

373 D Vintage Park Drive, Foster City, California 94404 Tel. 415/578-2600 Toll free: 1-800/248-6764 Fax: 415/578-2626

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).