The EM44 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The EM44 Glucose Control Solution For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

The EM44 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EM44 Glucose Control Solution For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

Device Description

AI/ML Overview

The provided text is a 510(k) summary from the FDA for a blood glucose monitoring system. It primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to predicate devices. It does not contain the detailed information required for an acceptance criteria table or a study description.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
MRMC comparative effectiveness study details (effect size, human reader improvement)
Standalone performance details
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The document confirms that the device is a Blood Glucose System (EM44 Pro and EM44 Self Monitoring Blood Glucose System) intended for quantitative measurement of glucose in whole blood. It also specifies its intended use for OTC and/or Prescription Use, and that it's not for diagnosis or screening of diabetes mellitus, nor for use on neonates.

To answer your questions, I would need access to the actual study reports, performance data, and other technical documentation that typically accompanies a 510(k) submission, but is not included in this summary letter.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Image /page/0/Picture/4 description: The image shows the text 'SEP 0 ? 2011'. The text appears to be a date, with 'SEP' likely representing September. The day is unclear due to the question mark, but the year is clearly '2011'. The text is in a simple, bold font.

EPS Bio Technology Corp. c/o Y.C. Lei General Manager No.8 R&D Rd III. Hsinchu Science Park Hsinchu City, Hsinchu China (Taiwan) 300

Re: K112272

Trade Name: EM44 Pro and EM44 Self Monitoring Blood Glucose System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR, NBW, JJX Dated: August 2, 2011 Received: August 8, 2011

Dear Mr. Lei:

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 111 (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); medical device 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).

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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 Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 800 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 regoring 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 for ( 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/or You/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, 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

510(k) Number (if known): K112272

Device Name: EM44 Self Monitoring Blood Glucose System

Indications For Use:

The EM44 Glucose Control Solution

For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (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 (OVD)

Division Sign-Off

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

510(k) K112272

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Indications for Use

510(k) Number (if known): K112272

Device Name: EM44 Pro Self Monitoring Blood Glucose System

Indications For Use:

The EM44 Glucose Control Solution

For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

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 (OVD)

signature

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

510(k) K112272

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.