The AutoSure HT Blood Glucose Monitoring System is intended for the quanitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

The AutoSure HT blood glucose meter and AutoSure HT test strips are used for testing of blood glucose. Contrex Plus 4 Glucose Control Solutions are used for quality control testing of the systems.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list numeric acceptance criteria for the device's accuracy in the way a typical performance study's pre-defined thresholds would. Instead, it states that "Results demonstrate substantial equivalence to the predicate system" and that "Clinical and non-clinical testing demonstrated that the AutoSure HT system performs in a substantially equivalent manner to that of the predicate."

However, we can infer the type of performance being evaluated. For Blood Glucose Monitoring Systems (BGMS), the primary performance metric related to accuracy is typically the comparison of results against a laboratory reference method. The document mentions "accuracy study" and "precision testing." While specific numerical criteria are not provided for the AutoSure HT, for BGMS devices, the FDA typically references ISO 15197 standards for accuracy, which often involve criteria like:

X% of results within Y mg/dL of the reference method for glucose concentrations < Z mg/dL
W% of results within V% of the reference method for glucose concentrations ≥ Z mg/dL

Since the document emphasizes "substantial equivalence to the predicate system," the acceptance criteria for the AutoSure HT would implicitly be that its performance is comparable to or better than the predicate's, and that it meets relevant industry standards for BGMS.

Acceptance Criterion (Inferred from industry standards and context)	Reported Device Performance (General Statement)
Accuracy (comparison to reference method)	"Results demonstrate substantial equivalence to the predicate system." (Implies meeting or exceeding predicate's accuracy, likely within ISO 15197 or similar standards).
Precision (repeatability and reproducibility)	Performed "precision testing," and found "substantial equivalence."
User Performance (ease of use, ease of understanding)	"Results demonstrate substantial equivalence to the predicate system."
Disinfection performance (robustness to cleaning)	"Results demonstrate substantial equivalence to the predicate system."
Other Non-Clinical (EMC, electrical safety, battery life, drop, software V&V, linearity, temp/humidity, sample volume, interferences, altitude, control solution qualification, hematocrit performance)	"Results demonstrate substantial equivalence to the predicate system."

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

Sample Size: The document does not explicitly state the sample sizes for the "accuracy study" or "user performance study."
Data Provenance: The studies were described as "An accuracy study was conducted with blood testing at finger, palm, and forearm sites by healthcare professionals. A User Performance study was conducted with self-testing at finger, palm, and forearm sites by home users..." The country of origin of the data is not specified, but the submitter is Apex Biotechnology Corp. in Hsinchu, CHINA (TAIWAN). It is typical for such studies to be prospective, but this is not explicitly stated.

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

Number of Experts: Not specified.
Qualifications of Experts: The accuracy study involved "blood testing... by healthcare professionals." The specific qualifications (e.g., medical technologists, nurses) or their years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for establishing ground truth or resolving discrepancies. For an accuracy study, the "ground truth" is typically established by a laboratory reference method, not by expert consensus adjudication of device readings.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers interpreting results produced by AI. This device is a blood glucose monitoring system, which provides a numerical output, not an image or complex diagnostic interpretation requiring human expert analysis that could be augmented by AI.

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

Yes, the primary clinical studies described (the "accuracy study" and "precision testing") represent standalone performance of the device's algorithm and hardware to measure blood glucose. The "user performance study" evaluates the human-device interaction but the core measurement is still standalone. The device outputs a numerical glucose value directly.

7. The Type of Ground Truth Used

For the "accuracy study," the ground truth would have been established by a laboratory reference method for glucose measurement. Common reference methods include hexokinase or glucose oxidase methods performed on a clinical chemistry analyzer in a certified laboratory setting. This is implied by the nature of a blood glucose monitoring system accuracy study.
For the "user performance study," the ground truth typically relates to the correctness of self-testing procedures and the readability/understandability of results and instructions, rather than a separate "truth" about the glucose level itself.

8. The Sample Size for the Training Set

This information is not provided. Blood glucose monitoring systems like the AutoSure HT are typically based on electrochemical principles and algorithms that are developed and calibrated using internal data (training/development sets), but the size of these internal sets is not disclosed in the 510(k) summary.

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

This information is not provided. Similar to the test set, the ground truth for any internal training or calibration performed during the development of the device's algorithm would be established using a laboratory reference method for glucose measurement.

Summary

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K131750

510(k) Summary

Submitter:	Apex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)
Contact Person:	Hsue-mei LeeManager of Quality Assurance DepartmentApex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	February 17, 2014
Trade Names:	AutoSure HT Blood Glucose Monitoring SystemAutoSure HT Blood Glucose Test StripsContrex Plus 4 Glucose Control Solutions
Classification:	Glucose test system, 21 CFR 862.1345, Class IISingle (specified) analyte controls (assayed and unassayed), Class I, 21CFR 862.1660
Product Codes:	CGA, NBW; JJX
Predicate Devices:	GAL-1A Blood Glucose Monitoring System (K113208)Contrex Plus III Glucose Control Solutions (K113098)
Device Description:	The AutoSure HT blood glucose meter and AutoSure HT test strips areused for testing of blood glucose. Contrex Plus 4 Glucose ControlSolutions are used for quality control testing of the systems.
Intended Use:	AutoSure HT Blood Glucose Monitoring SystemThe AutoSure HT Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertips, forearm, or palm. Alternative site testing shouldbe performed only during steady-state (when glucose is not changingrapidly). Testing is done outside the body (In Vitro diagnostic use). It isindicated for lay use by people with diabetes, as an aid to monitoring levelsin Diabetes Mellitus and should only be used by a single patient and it shouldnot be shared. It is not indicated for the diagnosis or screening of diabetes orfor neonatal use.AutoSure HT Blood Glucose Test StripsThe AutoSure HT Blood Glucose Test Strips are to be used with the AutoSureHT Blood Glucose Meter to quantitatively measure glucose in capillary wholeblood taken from fingertips, palm, or forearm.Contrex Plus 4 Glucose Control SolutionsThe Contrex Plus 4 glucose control solution is used with the AutoSure HTmeter and AutoSure HT test strips to verify that the meter and test strips areworking together properly and that the test is performing correctly.
Comparison ofTechnologicalCharacteristics:	The AutoSure HT meter has been modified relative to the predicate by minorchanges in external design and modifications of the test strip holder tosupport the hematocrit compensation feature. Meter software has beenaugmented to support the hematocrit compensation feature. The AutoSureHT test strip has been modified relative to the predicate by minor changes inchemistry [17% increase in glucose oxidase, 6% increase in electron shuttle],alteration of electrode tracks to support 8 calibration codes, and addition of asecond blood channel to support the hematocrit compensation feature. Thechemistry of the Contrex Plus 4 control solutions has been modified slightlyto increase viscosity.
Non-ClinicalTesting:	Testing was conducted as follows: EMC and Electrical Safety, test stripholder reliability testing, battery life verification, drop testing, disinfectionperformance (robustness of meter to multiple cleanings and disinfections),software verification and validation, and linearity testing with validation ofLo/Hi detection, temperature and humidity testing, sample volumeverification, precision testing, interferences testing, altitude testing,qualification of control solutions, hematocrit performance testing,Disinfection testing with recommended disinfectant wipes was done using ananimal virus test model. Results demonstrate substantial equivalence to thepredicate system.
Clinical Testing	An accuracy study was conducted with blood testing at finger, palm, andforearm sites by healthcare professionals. A User Performance study wasconducted with self-testing at finger, palm, and forearm sites by home users,including evaluation of ease of use and ease of understanding of the usermanual. Results demonstrate substantial equivalence to the predicate system.
Conclusion:	Clinical and non-clinical testing demonstrated that the AutoSure HT systemperforms in a substantially equivalent manner to that of the predicate. Weconclude that the AutoSure HT system is substantially equivalent to thepredicate system.

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510(k) Summary (Continued)

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510(k) Summary (Continued)

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Image /page/3/Picture/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with a stylized caduceus-like symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Centrol Center - WO66-G609
Silver Spring, MD 20993-0002 March 6, 2014

APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE,MANAGER, QA NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, CHINA (TAIWAN)

Trade/Device Name: AutoSure HT Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW, JJX Dated: January 24, 2014 Received: January 28, 2014

Dear Ms. Lee:

Re: K131750

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Lee

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CourtneyH.Lias-S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

: . . . Indications for Use

510(k) Number (if known) K131750

ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ

Device Name

AutoSure HT Blood Glucose Monitoring System

Indications for Use (Describe)

The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY · .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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.