The 3test® Glucose Supreme Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, 3test* Supreme Glucose Monitoring System only needs a small amount of blood ( 2μL. same as predicate device ). Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 5 seconds, and 200 blood glucose result memory.

AI/ML Overview

The provided text is a 510(k) summary for the "3test® Supreme Glucose Monitoring System." It states that the device is substantially equivalent to a predicate device (3test® Blood Glucose Monitoring System, K050224) and describes its intended use and basic technology. However, it does not include detailed acceptance criteria, specific performance metrics, or information about a comprehensive study that proves the device meets those criteria. The document focuses on regulatory approval based on equivalence rather than presenting an in-depth performance study with acceptance criteria and results.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Details for 3test® Supreme Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Not provided in source)	Reported Device Performance (Not provided in source)
Accuracy (e.g., % within +/- X mg/dL or +/- Y%)	N/A	N/A
Precision (e.g., %CV)	N/A	N/A
Linearity	N/A	N/A
Hematocrit Interference	N/A	N/A
Interfering Substances	N/A	N/A
Usability/Human Factors	N/A	N/A

Explanation: The document does not specify any quantitative acceptance criteria or report specific performance metrics for accuracy, precision, linearity, or other analytical performance characteristics. It relies on the claim of substantial equivalence to a predicate device (K050224) which is stated to have the "same working principle and technologies."

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

Sample Size for Test Set: Not provided.
Data Provenance: The document mentions "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA." However, it does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Not provided. The document does not describe the methodology for establishing ground truth for any test set.

4. Adjudication Method for the Test Set:

Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study is not mentioned as this is a glucose monitoring system, not an imaging device typically assessed with MRMC studies.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable in the typical sense for a glucose monitoring system. This device is used by individuals (patients or healthcare professionals) to obtain a reading. The performance relates to the accuracy of the sensor and meter, not an AI algorithm.

7. The Type of Ground Truth Used:

Not explicitly stated. For glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) to measure glucose levels in the same blood samples used for device testing. The document refers to "Pre-clinical and clinical data" but does not detail how ground truth was established for those studies.

8. The Sample Size for the Training Set:

Not applicable as this is a glucose monitoring system that uses electrochemical biosensor technology, not a machine learning or AI-based device that would typically have a "training set."

9. How the Ground Truth for the Training Set was established:

Not applicable for the same reason as above.

Summary of Device and Approval Basis:

The "3test® Supreme Glucose Monitoring System" uses an electrochemical biosensor and capillary action to measure glucose in whole blood. It requires 2μL of blood and provides results in 5 seconds. The device is intended for self-monitoring by people with diabetes at home and for use by healthcare professionals in clinical settings.

The 510(k) clearance (K072905) for this device was based on a claim of substantial equivalence to the predicate device, the "3test® Blood Glucose Monitoring System" (K050224). The manufacturer states that both devices use the "same test strips, have the same working principle and technologies." The differences noted are in the levels range of the control solution, battery number, memory results, and test strip lot calibration, which were deemed to not raise new safety or effectiveness aspects. The provided document details the regulatory approval process but does not contain the specific performance study data or acceptance criteria that would typically be reported in a technical validation study.

Summary

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510(K) Summary of Safety and Effectiveness II.

(Per 21 CFR 807.92)

2.1. General Information Establishment

510(k):	K072905
Manufacturer:	NEUERO ENGINEERING INC.
Address:	20F, No. 171, Cheng-Kuang Rd.,San-Chung City, 24160, Taipei County, Taiwan
Registration Number:	3004512547
Contact Person:	Dr. Ke-Min JenOfficial Correspondent886-3-5208829 (Tel)886-3-5209783 (Fax)
Date Submitted:	October 1, 2007
Device
Proprietary Name:	3test® Supreme Glucose Monitoring System
Classification Name:	SYSTEM, TEST, BLOOD GLUCOSE, OVERTHE COUNTER, Class II
Product Code:	NBW

2.2. Safety and Effectiveness Information

● Predicate Device:

Claim of Substantial Equivalence (SE) is made to NEUERO ENGINEERING INC.

-- 3test® Blood Glucose Monitoring System ( K050224 ).

Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, 3test* Supreme Glucose Monitoring System only needs a small amount of blood ( 2μL. same as predicate device ). Capillary action at the

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end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 5 seconds, and 200 blood glucose result memory.

Intended Use: .

The 3test" Supreme Glucose Test Strip is intended to measure the glucose in whole blood with the 3test" Supreme Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test" Supreme Glucose Monitoring System can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood.

. Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

. Substantial Equivalence (SE)

A claim of substantial equivalence is made to the predicate device NEUERO ENGINEERING INC. -- 31est" Blood Glucose Monitoring System ( K050224 ). Both of them used with the same test strips, have the same working principle and technologies. The differences are the levels range of the control solution, battery number, the memory results, and test Strip lot calibration. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent,

Ke. Zizter

Dr. Jen, Ke-Min Official Correspondent for NEUERO ENGINEERING INC.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The overall design is simple and monochromatic.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Neuero Engineering, Inc. c/o Dr. Ke-Min Jen Official Correspondent 20F, No. 171, Cheng-Kuang Road San-Chung City, Taipei County 241 Taiwan, ROC

APR 1 8 2008

Re: K072905

Trade Name: 3test Supreme Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA Dated: April 2, 2008 Received: April 7, 2008

Dear Dr. Jen:

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).

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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,

Jean M. Cooper, M.S., D.V.M.

Yéan 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

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Indication for Use

510(k) Number (if known): K072905

Device Name: 3test Supreme Glucose Monitoring System

Indication For Use:

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

Over the Counter Use X . (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 C. Benson

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

510(k) K072905

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.