GLYCOSAL II HBA 1C TEST

K011933 · Provalis Diagnostics , Ltd. · LCP · Nov 2, 2001 · Hematology

Device Facts

• Record ID: K011933
• Device Name: GLYCOSAL II HBA 1C TEST
• Applicant: Provalis Diagnostics , Ltd.
• Product Code: LCP · Hematology
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Glycosal™ II HbA1c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for use at home by diabetics as an indicator of overall glycaemic control. The Glycosal™ II HbA1c assay is intended for prescription home use.

Device Story

Glycosal™ II HbA1c Test is an in vitro diagnostic device for quantitative determination of glycated hemoglobin (HbA1c) in capillary blood. The device utilizes affinity chromatography to separate and measure HbA1c levels. It is designed for prescription home use by diabetic patients to monitor long-term blood glucose control. The patient collects a capillary blood sample via finger prick, which is then processed by the test system. The resulting measurement provides an indicator of overall glycaemic control, allowing patients and healthcare providers to assess the effectiveness of diabetes management strategies over time.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Affinity chromatography method for HbA1c quantification. Single-use in vitro diagnostic test. Designed for capillary blood samples obtained via finger prick.

Indications for Use

Indicated for known diabetics for monitoring time-averaged blood glucose levels as an indicator of overall glycaemic control. For prescription home use via capillary blood finger prick.

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

• Glycosal™ HbA1c test
• Metrika DRX HbA1c

Submission Summary (Full Text)

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K011933

| NOV 0 2 2001 510(k) Summary of safety and Effectiveness | | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| 1) Submitter<br>name, address,<br>contact | Owner/ Operator<br>Provalis Diagnostics Limited<br>Newtech Square<br>Deeside Industrial Park<br>Deeside<br>Flintshire CH5 2NT<br>UK | |
| | Contact Person: | Mrs Jan Barrack, Regulatory Affairs Manager |
| | Telephone: | [phone] |
| | Facsimile: | [phone] |
| | Email: | [e-mail] |
| | USA contact person | Thomas M Tsakeris |
| | Company | Devices and Diagnostics Consulting Group Inc. |
| | Address: | 16809 Briardale Road,<br>Rockville,<br>MD 20855<br>USA |
| | Telephone: | 301 330 2076 |
| | Facsimile: | 301 330 2568 |
| | Email: | [e-mail] |

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| | 2) Device name | Proprietary name: | Glycosal™ II HbA1c Test |
|--|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | | Common name: | Prescription Home use Test for the<br>Detection of Glycated Hemoglobin in<br>Human Whole Blood. |
| | | Classification: | ASSAY, GLYCOSYLATED<br>HEMOGLOBIN |
| | 3) Predicate<br>Device | The Glycosal™ II HbA1c test is substantially equivalent to<br>other products in commercial distribution for similar use,<br>including the Glycosal™ HbA1c test (primary predicate device)<br>and the Metrika DRX HbA1c, for prescription home use test<br>(secondary predicate device). | |
| | 4) Device<br>Description | Instrument read, single use <i>in vitro</i> test for the quantitative<br>determination of glycated hemoglobin (GHb) in diabetics. | |
| | 5) Intended use | The Glycosal™ II HbA1c test is an affinity chromatography<br>method and is intended for the <i>in-vitro</i> quantitative<br>determination of HbA1c in capillary blood taken from a finger<br>prick. | |
| | | The test is indicated for use by diabetics for monitoring the time<br>averaged blood glucose levels of known diabetics as an<br>indicator of overall glycaemic control. | |
| | | The Glycosal™ II HbA1c test is intended for use as a<br>prescription home use test. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Provalis Diagnostics Ltd. NOV 0 2 2001 c/o Mr. Thomas M. Tsakeris Devices and Diagnostics Consulting Group 16809n Briardale Road Rockville, MD 20855

k011933 Re:

Trade/Device Name: Glycosal™ II HbA1c Test Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: September 19, 2001 Received: September 20, 2001

Dear Mr. Tsakeris:

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 for ass been and 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 notification. The FDA inding of succeantary of successity of this, 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 1 If you desire specific article your do novelses), please contact the Office of Compliance at additionally 607.10 for in This alaglestions on the promotion and advertising of your device, [phone]. Rudationally, 2011 452-4639. 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 Information on your responsionals and Consumer Assistance at its toll-free number [phone] or Mandracturers International and Colabor. "http://www.fda.gov/cdrh/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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K011933

## NOV 0 2 2001

Intended Use/Indications for Use Statement

Unknown-not yet assigned by FDA 510(k) Number:

Glycosal™ II HbA1c Test Device Name:

Intended Use/Indications for Use Statement:

The Glycosal™ II HbA12 assay is an affinity chromatography method and is intended The Glycosal™ II HbAıs assay is an allindy Chromatography in capillary blood taken from a
for the in-vitro quantitative determination of HbAıs in capillary blood taken from finger prick.

The test is indicated for monitoring the time averaged blood glucose levels of known The test is indicated for monitoning the time avolugue are a seems.
diabetics, for use at home by diabetics as an indicator of overall glycaemic control.

The Glycosal™ II HbA1e assay is intended for prescription home use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Qurhim-Bautista

sion Sygn-Only
ion of Clinical Laboratory Devices Koll933 510(k) Number