The CLOVER Alc HbAlc assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER Alcim is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

The CLOVER Alc 11 glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER Alc 10 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

Device Description

The CLOVER A1cm is a device which combines a Hemoglobin A1c monitoring system, and a blood glucose monitoring system.

The CLOVER A1c™ monitoring system includes Hemoglobin A1c Analyzer, Hemoglobin A1c Test cartridge, Hemoglobin A1c Check cartridge, Thermal printer, Barcode scanner, PC cable, and Fan filter.

The CLOVER A1c™ monitoring system is a fully automated boronate affinity assay for the determination of the percentage of hemogiobin A1c (HbA1c %) in human whole blood.

Hemoglobin A1c Test cartridge is composed of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin A1c, with a collection leg for blood sample collection.

The reagent pack is pre-filled with reaction solution and washing solution. The reaction solution contains agents that lyse erythrocytes and bind hemoglobin specifically, as well as a boronate resin that binds cis-diols of glycated hemoglobin.

Blood sample is collected at the collection leg of the reagent pack, and then the reagent pack is inserted into the cartridge. The assembled cartridge is inserted into the Hemoglobin A1c Analyzer and rotated so that the blood sample mixture is placed at the measurement zone of the cartridge, where the amount of total hemoglobin in the blood sample is photometrically measured. The measurement range is 4.0~14.0%. Acceptable anticoagulants for venous samples are EDTA, heparin, citrate and fluoride/oxalate.

The CLOVER A1c™ Glucose module is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

AI/ML Overview

The provided text is a 510(k) summary for the CLOVER A1c™ Glycosylated Hemoglobin Monitoring System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, it does not provide explicit acceptance criteria or a detailed study report that proves the device meets specific criteria.

The document states that "Clinical: The clinical performance evaluation using the CLOVER A1c™ device was conducted for the purpose of validating the glycosylated hemoglobin and glucose measuring accuracy. Test results showed substantial equivalence." and "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the CLOVER A1c™ with respect to predicate devices. Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence."

This indicates that a study was performed, but the results and the specific acceptance criteria are not detailed in this summary. The "acceptance criteria" appear to be implicit in demonstrating "substantial equivalence" to the predicate devices, meaning the CLOVER A1c™ performs "as well as" the predicate devices. Without access to the full study report, specific numerical acceptance criteria cannot be extracted.

Therefore, much of the requested information cannot be directly fulfilled from the provided text.

Here is what can be inferred or explicitly stated from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not provided in the 510(k) summary, a table detailing them cannot be created. The document broadly states that "Test results showed substantial equivalence" for both glycosylated hemoglobin and glucose measuring accuracy, and "Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence."

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

This information is not provided in the 510(k) summary. The summary mentions a "clinical performance evaluation" but does not specify the sample size, country of origin, or whether the data was retrospective or prospective.

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

This information is not provided in the 510(k) summary. The document does not describe the methodology for establishing ground truth for the clinical performance evaluation.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. There is no mention of adjudication methods.

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

There is no indication of an MRMC comparative effectiveness study in the provided text. The device is for in vitro diagnostic use, and the performance claims relate to quantitative measurement accuracy, not human reader interpretation of images. Therefore, an MRMC study is unlikely to be relevant or performed for this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

For this type of in vitro diagnostic device (quantitative measurement of A1c and glucose), the "standalone" performance is the primary mode of operation. The device itself performs the measurement. The "clinical performance evaluation" would inherently be a standalone evaluation of the device's accuracy in measuring the target analytes.

7. The Type of Ground Truth Used

The ground truth for devices like this typically involves comparison to a recognized reference method (e.g., HPLC for HbA1c, or a laboratory-grade glucose analyzer calibrated to a standard reference method). While not explicitly stated, the "clinical performance evaluation" would have used a highly accurate and precise method to establish true HbA1c and glucose values in human whole blood samples, against which the CLOVER A1c™ device's measurements were compared. It would likely be analytical measurements from a reference laboratory, not expert consensus or pathology in the sense of imaging.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. As an in vitro diagnostic device that relies on biochemical reactions and photometric/electrochemical measurements, it's less likely to have a "training set" in the machine learning sense, but rather a robust development and validation process using various samples to define its operational parameters.

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

This information is not provided in the 510(k) summary. Similar to point 8, if a "training set" exists (e.g., for calibrating the device or refining algorithms for measurement), the ground truth would have been established using reference methods, but this is not detailed in the summary.

Summary

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510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: January 13, 2010

JAN 1 4 2010

Submitter: 1.

Submitted by:	Infopia Co.,ltd.#891, Hogye-dong, Dongan-GuAnyang, Kyunggi 431-080, KoreaPhone +82-31-460-0400Fax +82-31-460-0401
Official Correspondent:	Maria Griffinmdi Consultants, Inc.55 Northern Blvd., Ste. 200, Great Neck, NY 11021516-482-9001
Company Contact:	Bryan OhPhone: 1-321-267-9911Fax: 1-321-267-5582

Device: 2.

Propriety Name	CLOVER A1c ™
Common Name	Test system for hemoglobin A1c, blood glucose
Classification Name:	Glycosylated Hemoglobin test systemBlood glucose test system
Classification:	Class II21 CFR Part 864.747021 CFR Part 862.1345
Product Code:	CGA, LCP

3. Predicate Device:

DCA Vantage™, Test system for hemoglobin A1c, albumin and creatinine, K071466 Evolution™, Blood glucose monitoring system, K072369

4. Description:

The CLOVER A1cm is a device which combines a Hemoglobin A1c monitoring system, and a blood glucose monitoring system.

The CLOVER A1c™ monitoring system includes Hemoglobin A1c Analyzer, Hemoglobin A1c Test cartridge, Hemoglobin A1c Check cartridge, Thermal printer, Barcode scanner, PC cable, and Fan filter.

The CLOVER A1c™ monitoring system is a fully automated boronate affinity assay for the determination of the percentage of hemogiobin A1c (HbA1c %) in human whole blood.

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5. Indications for use:

The CLOVER A1c M HbA1c assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

The CLOVER A1c™ glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

6. Comparison of Technological Characteristics with Predicate:

The CLOVER A1c™ has the same technological characteristics as the curent legally
marketed predicate devices, DCA Vantage ™ (K071466) by Siemens medical solutions diagnostics and Evolution 114 (K072369.) by Infopia Co., Ltd.

7. Performance Data:

Clinical: The clinical performance evaluation using the CLOVER A1c™ device was conducted for the purpose of validating the glycosylated hemoglobin and glucose measuring accuracy. Test results showed substantial equivalence.

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the CLOVER A1c™ with respect

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to predicate devices. Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence.

8. Conclusion:

The conclusion drawn from the clinical and non clinical tests is that the CLOVER A10™ is as safe, as effective, and performs as well as the legally marketed predicate device, the DAC Vantage TM and Evolution TM.

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Image /page/3/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 symbol that resembles an abstract human figure embracing or protecting something, with three curved lines representing the figure's arms or embrace.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Infopia Co., Ltd. c/o Ms. Maria F. Griffin Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

JAN 1 4 2010

Re: K082275

Trade Name: Clover Alc™ Glycosylated Hemoglobin Monitoring System Regulation Number: 21 CFR §864.7470 Regulation Name: Hemoglobin Alc Test System. Regulatory Class: Class II Product Codes: LCP, CGA Dated: January 8, 2010 Received: January 11, 2010

Dear Ms. Griffin:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney C. Harper, Ph.D. 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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Indication for Use

510(k) Number (if known): K082275

Device Name: CLOVER A1c™ Glycosylated Hemoglobin Monitoring System

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And /Or

Over the Counter Use (21 CFR Part 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)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K082275

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).