SmartLink™ GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink™ GOLD meter must be used with SmartLink™ GOLD blood glucose test strip and SD Control solutions.

The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results.

Testing is done outside the body (in vitro diagnostic use).

This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in · clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

Device Description

The SmartLink™ GOLD Blood Glucose System is an Rx/OTC blood glucose system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.

The SmartLink™ GOLD Blood Glucose System consists of a SmartLink™ GOLD Blood Glucose Meter which measures and displays test results, SmartLink™ GOLD test strip, lancet and lancing device for blood sampling, control solution to check the meter and test strip, check strip to check the meter, 3 V battery (type 2032) for power, carrying case, user guide, packaging inserts for the test strip and control solution and a Quick Guide for helping the user with a self test diary to document test results for monitoring the trend of blood glucose.

The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The svstem can also set the pre-meal and postmeal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with EN ISO 15197:2003. This standard outlines specific accuracy criteria for blood glucose monitoring systems. While the exact numerical criteria from the standard are not explicitly listed in this document, the submission confirms that the device "met all relevant standards requirements" (Page 3).

Acceptance Criteria (Based on EN ISO 15197:2003, typically)	Reported Device Performance
Not explicitly stated in the document, but for lay-user operated blood glucose systems, EN ISO 15197:2003 generally requires: - 95% of results to be within ±15 mg/dL of the reference method for glucose concentrations <100 mg/dL. - 95% of results to be within ±15% of the reference method for glucose concentrations ≥100 mg/dL. (Note: These are common interpretations of the standard; the precise criteria may vary slightly within the standard's nuances.)	The System Accuracy Evaluation (Method Comparison with Predicate Device) was performed according to EN ISO 15197:2003. The conclusion states that "documentation supplied with this submission... demonstrates that the subject device is as safe, as effective, and performs as well as our legally marketed predicate device." This implies the device met the ISO standard's criteria.

Acceptance Criteria (Based on EN ISO 15197:2003, typically)

Reported Device Performance

Not explicitly stated in the document, but for lay-user operated blood glucose systems, EN ISO 15197:2003 generally requires: - 95% of results to be within ±15 mg/dL of the reference method for glucose concentrations <100 mg/dL. - 95% of results to be within ±15% of the reference method for glucose concentrations ≥100 mg/dL. (Note: These are common interpretations of the standard; the precise criteria may vary slightly within the standard's nuances.)

The System Accuracy Evaluation (Method Comparison with Predicate Device) was performed according to EN ISO 15197:2003. The conclusion states that "documentation supplied with this submission... demonstrates that the subject device is as safe, as effective, and performs as well as our legally marketed predicate device." This implies the device met the ISO standard's criteria.

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

Sample Size for System Accuracy Evaluation (Method Comparison): Not explicitly stated.
Sample Size for User Performance Study: Not explicitly stated.
Data Provenance: The manufacturing sites and submitter's identification are in Kyonggi-do, KOREA. The clinical studies were performed in conjunction with the submission requirements, but the specific country of origin for the patient data is not mentioned. It is a prospective study implied by the performance of the studies to support a 510(k) submission.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The "Method Comparison with Predicate Device" implies a comparison to a referencemethod, which would typically be laboratory-based and overseen by qualified laboratory personnel.

4. Adjudication Method for the Test Set

No adjudication method is described. The "Method Comparison with Predicate Device" usually involves comparing device readouts to a laboratory reference method, not a consensus among multiple human readers.

5. 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

No MRMC study was done. This device is a blood glucose monitoring system, which directly provides a numerical measurement, so the concept of human readers and AI assistance in interpretation does not apply in the context of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The "System Accuracy Evaluation (Method Comparison with Predicate Device)" is inherently a standalone performance assessment of the device against a reference standard. The "User performance study" also assesses the device's performance, albeit with lay users operating it.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The ground truth for the system accuracy evaluation would have been established by a laboratory reference method (e.g., a central lab analyzer using a hexokinase or glucose oxidase method), as is standard for blood glucose monitor comparisons. This is implied by "Method Comparison with Predicate Device" according to EN ISO 15197:2003.

8. The Sample Size for the Training Set

Not applicable / not explicitly stated. For a blood glucose monitoring system, there isn't a "training set" in the sense of machine learning algorithms for image recognition or similar domains. The device's calibration and algorithm are developed during manufacturing and validated through rigorous testing. The clinical studies are for validation, not training.

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

Not applicable. As noted above, typical blood glucose monitors do not use a machine learning "training set" with ground truth in the same way modern AI algorithms do. The "ground truth" for the device's internal calibration and algorithm development would come from precision reference standards and established chemical measurement principles.

Summary

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and the control control consideration of the JUN - 9 2010

Exhibit #1

510(K) SUMMARY

.. . . . . . . . . .

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:_k100398

1. Submitter's Identification:

Standard Diagnostics, Inc.

Head Office:

156-68 Hagal-dong, Giheung-gu, Yongin-si, Kyonggi-do, 446-930 KOREA

Tel: 82-31-899-9818 FAX: 82-31-899-9755

Manufacturing Site:

C-4th & 5th Floor Digital Empire Building 980-3 Yeongtong-dong, Yeongtong-gu Suwon-si, Kyonggi-do 443-702 KOREA

Tel: 82-31-300-0423 FAX: 82-31-300-0499

Contact:

Mr. Sun Young Jeong QA/RA Manager Standard Diagnostics, Inc.

Date Summary Prepared: June 7, 2010

1. Name of the Device:
  SmartLink™ GOLD Blood Glucose Monitoring System

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Common or Usual Name:Blood·Glucose Test System, Over-the-Counter 3.

Predicate Device Information: 4.

SD CHECK GOLD Blood Glucose Monitoring System, K082683

5. Device Description:

6. Intended Use:

SmartLink™ GOLD Blood Glucose Monitoring System is indicated for monitoring qlucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink™ GOLD meter must be used with SmartLink™ GOLD blood glucose test strip and SD Control solutions.

The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results. and and personal programment and province and comments of the comments of . . . . . . . . . . . . .

Testing is done outside the body (in vitro diagnostic use).

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This system is indicated for home (over-the-counter, OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

7. Comparison to Predicate Devices:

The SmartLink 100 GOLD Blood Glucose System is substantially equivalent to our SD CHECK GOLD Blood Glucose Monitoring System, K082683 with the main difference being no coding (one code). Both the subject and predicate devices are similar in intended use and basic fundamental scientific technology with differences in:

A. SmartLink™ GOLD Meter
Appearance, Size, Weight, Color, Codechip, PCB, LCD, MCU
B. SmartLinkTM GOLD Test strip Printed Film, shelf life

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Based on our risk analysis evaluation results, and, in accordance with the FDA "Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems, 10/24/06", outlined performance characteristics, the following testing was conducted to support the modifications found in our subject device:

Software Verification and Validation Testing .
. Precision Evaluation" (Exhibit #11)
. Linearity Testing
. Performance Evaluation at Sea Level and High Altitude
Equipment Temperature & Humidity Exposure Test .
Mechanical Resistance to Vibration-Environmental Testing .
Document TD-8 Testing Temperature Study .
Electromagnetic Compatibility Study (EN ISO 15197:2003) .
Electrical Safety Study (IEC 61010-1 & IEC 61010-2) .

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None of the testing demonstrated any design characteristics that violated the requirements of the FDA recognized standards or resulted in any safety hazards. It was our conclusion that testing met all relevant standards requirements.

9. Discussion of Clinical Tests Performed:

1 Clinical sensitivity and clinical specificity testing is not applicable.

A system accuracy evaluation (Method Comparison with Predicate Device) for the SmartLink™ GOLD Blood Glucose Monitoring System was performed according to EN ISO 15197:2003

A user performance study was performed to demonstrate that lay consumers could obtain accurate results using the SmartLink " GOLD Blood Glucose Monitoring System. The study was performed using capillary whole blood from fingertip, palm, forearm, and upper arm sample sites.

10. Conclusions:

Based on documentation supplied with this submission, conclusions drawn from clinical and bench testing of the subject device demonstrates that the subject device is as safe, as effective, and performs as well as our legally marketed predicate device.

12 un any is

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Public Health Service

Building 66

Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem. The seal is black and white.

Standard Diagnostics, Inc. c/o Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021-1734

Re: K100398

Trade/Device Name: SmartLink GOLD Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW. CGA Dated: May 7, 2010 Received: May 10, 2010

Dear Ms. Goldstein-Falk:

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 class II (Special Controls), 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).

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.

JUN 0 3 2000

Silver Spring, MD 20993

Food & Drug Administration

10903 New Hampshire Avenue

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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/ResourcesforYou/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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Indications for Use Statement

510(k) Number

... .. .. .. K100398

Device Name

SmartLink™ GOLD blood glucose monitoring system

INDICATIONS FOR USE

The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results.

Testing is done outside the body (in vitro diagnostic use).

This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in · clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (Part 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 (OIVD) - - - -

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) R100398

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.