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

NOTE:
a. the 3test is to be used with capillary whole blood from the fingertip
b. the 3test is not for use with neonates
b. the stest meter is to be used with the 3test Blood Glucose Test Strip, and the 3test High and Low Glucose Control Solutions

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, 3test® Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 5 seconds, and 100 blood glucose result memory.

AI/ML Overview

Here's an analysis of the provided text regarding the 3test® Glucose Monitoring System, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided text does not include specific acceptance criteria or the full study details that would typically be found in a comprehensive medical device submission. It primarily focuses on the device's administrative details, its intended use, and its claim of substantial equivalence to a predicate device.

However, based on the information provided, we can infer some aspects and highlight what's missing:

Acceptance Criteria and Reported Device Performance

The document states, "your blood glucose result is precisely and displayed in 5 seconds." This implies a performance claim related to speed and accuracy, but it doesn't quantify "precisely" with specific numerical acceptance criteria (e.g., accuracy within a certain percentage of a reference method).

Inferred Acceptance Criteria & Reported Performance (Based on limited information):

Acceptance Criteria (Inferred)	Reported Device Performance (From Text)
Blood glucose measurement speed	Displays results in 5 seconds
Blood glucose measurement accuracy	"Precisely" (Lacks specific numerical parameters like bias, CV, or percentage within a certain range of a reference method, as typically required).
Memory capacity for blood glucose results	100 blood glucose result memory
Compatibility with blood sample type	Uses whole blood (capillary whole blood from the fingertip)
Suitability for home use by individuals with diabetes	Intended for self-monitoring at home by persons with diabetes
Suitability for clinical use by professionals	Can be used at clinical sites by nurses or professional people
Not for neonatal use	Specifically states "not for use with neonates"
Compatibility with specific components	To be used with 3test Blood Glucose Test Strip, and 3test High and Low Glucose Control Solutions

Key Missing Information for Acceptance Criteria:

Numerical Accuracy Targets: The most critical missing piece is the quantitative acceptance criteria for accuracy (e.g., ISO 15197 standards like 95% of results within ±15 mg/dL or ±15% of a reference method for concentrations >100 mg/dL).
Precision/Repeatability/Reproducibility: No data on the variability of the device's measurements.
Interference Studies: No mention of testing for interference from common substances in blood.
User Performance Studies (for home use): No details on studies demonstrating that lay users can operate the device correctly and achieve accurate results.
Linearity/Measuring Range: The range of blood glucose values over which the device is accurate is not specified.

Study Information:

The document broadly 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." However, it does not provide any specific details about these studies.

Here's a breakdown of what we can and cannot answer based on the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The text does not mention the sample size for any clinical or pre-clinical studies, nor does it specify the data provenance (e.g., country, retrospective/prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. The document makes no reference to experts or the establishment of ground truth for any test sets. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus as in imaging.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. For a quantitative device like a blood glucose meter, ground truth is usually an objective lab reference measurement, not a consensus among experts. No such method is mentioned.
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 device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study is not relevant to this technology.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- Implied, but details are missing. A blood glucose meter inherently operates as a standalone device to measure glucose levels. Its "performance" would be the accuracy of its measurement against a reference. However, the study details validating this standalone performance (e.g., against a laboratory analyzer) are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but inferred to be a laboratory reference method. For a blood glucose meter, the "ground truth" for clinical studies would typically be a highly accurate and precise laboratory reference method (e.g., hexokinase method on a clinical chemistry analyzer). The document does not describe how ground truth was established, only that "Pre-clinical and clinical data are employed."
The sample size for the training set.
- Not applicable/Not provided. Blood glucose meters based on electrochemical biosensor technology generally do not employ machine learning algorithms that require a "training set" in the conventional sense of AI/ML. Their performance is based on the chemical and electrical properties of the test strip and meter. If there were any internal calibration or factory adjustments involving data, it's not described as a "training set."
How the ground truth for the training set was established.
- Not applicable/Not provided for the same reasons as point 7.

Summary

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K050224

510(K) Summary of Safety and Effectiveness II.

(Per 21 CFR 807.92)

JUL 1 3 2005

2.1. General Information Establishment

Manufacturer:	NEUERO ENGINEERING INC.
Address:	20F, No. 171, Cheng-Kuang Rd.,San-Chung City, 241, Taipei County, Taiwan
Registration Number:	3004512547
Contact Person:	Dr. Ke-Min JenOfficial Correspondent886-3-5208829 (Tel)886-3-5209783 (Fax)
Date Submitted:	January 26, 2005
Proprietary Name:	3test® Glucose Monitoring System3TM678G
Common Name:	Blood Glucose Monitoring System
Classification Name:	SYSTEM, TEST, BLOOD GLUCOSE, Class II.

2.2. Safety and Effectiveness Information

. Predicate Device:
Claim of Substantial Equivalence (SE) is made to BAYER Corp. -- Glucometer Elite Blood Glucose Meter ( K964630 ).
Based on an electrochemical biosensor technology and the ● Device Description: principle of capillary action, 3test® Glucose Monitoring System only needs a small Capillary action at the end of the test strip draws the blood into amount of blood.
3

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the action chamber and your blood glucose result is precisely and displayed in 5 seconds, and 100 blood glucose result memory.

Intended Use: ●

The 3test® glucose test strip is intended to measure the glucose in whole blood with the 3test® Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test® 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 BAYER Corp. --Glucometer Elite Blood Glucose Meter (K964630). Both of them have the same The differences are control solution, working principle and technologies. dimensions of the unit and strip, the time of auto shut off, memory results, and test There are no safety and effectiveness aspects arising from the subject time. device. They are substantially equivalent.

Ke-Mo-Ja

Dr. Jen, Ke-Min Official Correspondent for neuero engineering Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines above it, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol in a circular fashion. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 3 2005

Neuero Engineering Inc. c/o Dr. Ke-Min Jen Cro Dr. its its interest Industrial Research Society No.58, Fu-Chiun St. Hsin-Chu City, China Taiwan 300

K050224 Re:

K02022-1
Trade/Device Name: 3test Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: July 2, 2005 Received: July 6, 2005

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we have reviewed your Section 9 ro(t) premium in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreasure) to regally management date of the Medical Device American Frank Food. Drus commerce prof to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices mat have been recultion in accessariou of a premarket approval application (PMA). and Cosment ACT (Act) that do not require approvise the general controls provisions of the Act. The You may, merclore, market the device, bacycer of the more of registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 aco've) irrols. Existing major regulations affecting your cevice It may be subject to Such additional controllar Blassis on Parts 800 to 895. In addition, FDA can be found in Title 21, Cour of Concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does no mean Flease be advised that I Dri 3 issualise or our device complies with other requirements of the Act that I DA has made a decemination administered by other Federal agencies. You must of ally I edital statutes and regations and limited to: registration and listing (21 cumply with an the Free Frequire.nems 801 and 809); and good manufacturing practice CFR Part 8077, labeling (in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification: "The PDATmaing of bassana" - pur 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, of In If you desire specific information advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and and 1948 - Also moses of questions on the promotion and advertising or your and Safety at (240) 276-0484. Also, please note the Vitro Diagnostic Device Lyanaaton and Barey at (21)FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket the Aat from the You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting 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

510 (K) Number ( If Known ): ূK 050224

Device Name: 3test® Glucose Monitoring System, 3TM678G-

Indications For Use:

NOTE:

a. the 3test is to be used with capillary whole blood from the fingertip
b. the 3test is not for use with neonates
b. the stest meter is to be used with the 3test Blood Glucose Test Strip, and the 3test High and Low Glucose Control Solutions

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off
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In Vitro Diagnostic Device
Evaluation and safety

K050224
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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.