The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck 1 Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

Device Description

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 consists of a blood glucose meter, blood glucose test strips, control solutions, the lancing device, and lancets. The meter also comes with a speaking function that provides audible test results for users with low vision. The SuperCheck 1 Model 6268 allows the forearm to be used as an alternate site. User performance testing was conducted to support an over-the-counter indication.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the SuperCheck 1 Blood Glucose Monitoring System, Model 6268, based on the provided 510(k) summary:

Please note: The provided document is a 510(k) summary, which often provides a high-level overview of performance studies without detailing every specific acceptance criterion or the exhaustive data from the studies themselves. Therefore, some requested information (like specific numerical acceptance criteria or full study details) is not explicitly present in the provided text. I will extract what is available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (where available)	Reported Device Performance
Accuracy / Performance	Demonstrated satisfactory performance for intended use.	Studies demonstrated that the performance of the SuperCheck 1 system meets its intended use. The device is suitable for its intended use and substantially equivalent to the predicate device.
Intended Use	Quantitative measurement of glucose in fresh capillary whole blood from the finger and forearm. Use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring effectiveness of a diabetes control program. Not for diagnosis/screening or neonates. Alternative site testing (forearm) only during steady-state blood glucose conditions.	The device fulfilled all aspects of its stated intended use.
Equivalency	Equivalent technological characteristics and intended use as the predicate device (Prodigy Voice Blood Glucose Monitoring System).	The SuperCheck 1 has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System.
Alternate Site Testing	Support for forearm as an alternate site.	User performance testing was conducted to support an over-the-counter indication, including the forearm as an alternate site.

Missing specific quantitative acceptance criteria: The 510(k) summary does not list specific numerical accuracy or precision acceptance criteria (e.g., % within ±15% of reference, ISO standards for blood glucose meters). It only states that the performance was "satisfactory" and "meets its intended use."

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

Sample Size: Not explicitly stated. The document mentions "The performance... was studied in the laboratory and in clinical settings by healthcare professionals and lay users," but does not provide specific numbers for participants or conducted tests.
Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address in Taiwan, it's possible that at least some studies were conducted there, but this is not confirmed.

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

This information is not provided in the 510(k) summary. For blood glucose monitoring systems, ground truth is typically established using a highly accurate reference method (e.g., a laboratory analyzer), rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of medical images or records to establish a consensus ground truth. For a blood glucose meter, ground truth is established by a reference laboratory method, not expert adjudication in this manner.

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

No. An MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. For a blood glucose meter, the performance is standalone, measuring the device's accuracy against a reference standard.

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

Yes, a standalone performance study was done. The performance studies described in the summary ("in the laboratory and in clinical settings") relate to the device's ability to accurately measure blood glucose levels by itself. The results are compared directly to a reference method (though the reference method isn't specified in this summary). This is the primary mode of evaluation for a blood glucose monitoring system.

7. The Type of Ground Truth Used

While not explicitly stated in detail, the ground truth for blood glucose monitoring systems is invariably established by a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). This is the standard practice for evaluating the accuracy of blood glucose meters. It is not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

This information is not provided. The 510(k) summary focuses on the performance studies (testing data). Details about the training set size for the device's internal algorithms (e.g., for calibration) are not typically included in these summaries unless they are part of a novel machine learning component that requires extensive training data.

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

This information is not provided. Similar to question 8, the details of how any internal algorithms were trained or calibrated, and how their ground truth was established, are not included in this high-level 510(k) summary. It's likely that if a reference method was used for validation (testing), a similar or identical method would have been used for calibration/training.

Summary

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K091815

510(k) Summary

NOV 1 6 2009

Submitter Information 1.

Company name	Biotest Medical Corporation
Contact person	Maggie Chu, President
Address	No. 3-2, Chien-kuo Road, TEPZ Tantzu
	Taichung 427, Taiwan
	Republic of China
Phone	866 4-2532-6668
Fax	866 4-2532-6593

2. Name of Device

Trade Name	SuperCheck 1 Blood Glucose Monitoring System, Model 6268
Common Names	Blood Glucose MeterBlood Glucose Test Strips
Classifications	NBW, Over the Counter Blood Glucose Test, 862.1345CGA, Glucose Oxidase, 862.1345Class II device

Predicate Device 3.

Prodigy Voice Blood Glucose Monitoring System Trade/Proprietary Common/Usual NameBlood Glucose Meter

	Blood Glucose Test Strips
Submitter	Diagnostic Devices Inc.
510(k) Number	K073118

Device Description 4.

Intended Use 5.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

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This system contains a speaking function that provides audible test results for users with low vision.

Comparison to Predicate Device 6.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System; however, the SuperCheck 1 has one alternate site at this time, the forearm.

7. Performance Studies

The performance of the SuperCheck 1 Blood Glucose Monitoring System, Model 6268 was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of the SuperCheck 1 system meets its intended use.

Conclusion 8.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 demonstrates satisfactory performance, is suitable for its intended use, and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract image of an eagle.

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

NOV 1 6 2009

Biotest Medical Corporation c/o Diane Mandell Horwitz, Ph.D., RAC Mandell Horwitz Consultants, LLC 2995 Steven Martin Dr., Fairfax, VA 22031

Re: K091815 SuperCheck 1 Blood Glucose Monitoring System Trade/Device Name: Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: October 29, 2009 Received: November 2, 2009

Dear Ms. Mandell Horwitz

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 I carrest surfields and regarding but not limited to: registration and listing (21 CFR Part 807); labeling (21 Act of equirements, and good manufacturing practice requirements as set forth in the quality systems {OS} 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.

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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,

Signature

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 Form

510(k) Number: K091815

Device Name: SuperCheck 1, Model 6268

Indications for Use:

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (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 Devices (OIVD)

Page 1 of 1

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K091815

Page 1 of

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.