The PocketChem EZ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The PocketChem EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Description

The PocketChem EZ Blood Glucose Monitoring System consists of a meter, test strips, and two levels of control solutions for use as an aid to monitor the effectiveness of diabetes control.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PocketChem EZ blood glucose monitoring system, based on the provided FDA 510(k) summary:

Please note: The provided document is a 510(k) summary, which is a high-level overview. It typically does not contain the granular detail found in a full study report or detailed FDA review. Therefore, some specific details, particularly around statistical methods, exact sample sizes for each test type, and expert qualifications for ground truth determination, are not explicitly stated in this summary.

Acceptance Criteria and Reported Device Performance

The 510(k) summary indicates that "Bench testing included evaluation of interferences, linearity, linear range, hematocrit effects, altitude effects, control solution functionality, and analytical precision. Clinical testing included evaluation of accuracy for finger stick and palm test sites."

However, the provided text does not explicitly list the quantitative acceptance criteria for these tests (e.g., specific bias limits, precision CVs, or accuracy percentages within certain zones). It only states that the "bench testing results and clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate."

Without the specific numerical acceptance criteria, it's impossible to create a table with "Reported Device Performance" alongside defined "Acceptance Criteria." The summary implies that the device met internal and FDA-recommended criteria for blood glucose monitoring systems, but these criteria are not detailed here.

Study Details

A table of acceptance criteria and the reported device performance
- Not explicitly provided in the document. The 510(k) summary states that "A full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems." This implies that the device met the generally accepted performance standards for blood glucose meters at the time for accuracy (e.g., ISO 15197 or FDA guidance documents), precision, linearity, and interference. However, the specific numerical targets and results are not included in this summary.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests. The summary mentions "clinical testing," which typically involves patient samples. FDA guidance for blood glucose meters usually requires a minimum number of subjects (e.g., 100-150 subjects) for accuracy studies.
- Data Provenance: Not explicitly stated. Given ARKRAY Factory USA, Inc. is based in Minneapolis, MN, it is likely that at least some, if not all, clinical data was collected in the USA, but this is an inference.
- Retrospective or Prospective: Not explicitly stated, but clinical accuracy studies for medical devices are generally prospective.
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 applicable in the same way as imaging studies. For blood glucose meters, the "ground truth" (reference method) is typically established by laboratory-based analyzers (e.g., YSI analyzer) operated by trained laboratory technicians, not by expert consensus or interpretations of images by clinicians. The summary does not specify the number or qualifications of the individuals performing the reference measurements, but it's assumed they were trained laboratory personnel.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are making subjective interpretations (e.g., radiologists reviewing images) and their disagreements need to be resolved. For objective measurements like blood glucose, a highly accurate laboratory reference method (the "ground truth") is used against which the device's readings are compared.
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
- No. This is not relevant for a blood glucose monitoring system. MRMC studies are used for diagnostic imaging devices where human interpretation plays a role and the AI might assist that interpretation. The PocketChem EZ is a direct measurement device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The accuracy and precision studies performed for blood glucose meters are standalone evaluations of the device's performance against a reference method. The device provides a quantitative measurement directly, without requiring human interpretation of an output that needs to be "assisted." The clinical testing for "accuracy for finger stick and palm test sites" refers to this standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Laboratory Reference Method: For blood glucose monitoring systems, the ground truth is established by a highly accurate laboratory-based reference method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in clinical laboratories. The summary doesn't explicitly name the reference method but "clinical testing included evaluation of accuracy" implies comparison to such a standard.
The sample size for the training set
- Not applicable for this type of device. Blood glucose meters are not typically "trained" in the way AI algorithms are. Their underlying chemical/enzymatic reactions and electronic algorithms are designed and calibrated during development, not "trained" on large datasets of patient results in the sense of machine learning.
How the ground truth for the training set was established
- Not applicable. As above, there isn't a "training set" with ground truth in the machine learning sense for a blood glucose meter. The device's calibration and performance are validated against standard glucose solutions and patient samples measured by a reference method.

Summary

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K0906653

DCT - 9 2009

8 510(k) Summary

Submitter:	ARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439
Contact Person:	Hamid IdrissiRegulatory Affairs Project ManagerARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439Phone: 952-646-3171Fax: 952-646-3110idrissih@ARKRAYusa.com
Date Prepared:	March 9, 2009
Trade Name:	PocketChem EZ
Classification:	Glucose test system, 21 CFR 862.1345 and 862.1660; Class II
Product Codes:	CGA, NBW, JJX
Predicate Device:	Ferrara Meter (K063068)
Device Description:	The PocketChem EZ Blood Glucose Monitoring System consists of ameter, test strips, and two levels of control solutions for use as an aidto monitor the effectiveness of diabetes control.
Intended Use:	The PocketChem EZ Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose in fresh capillary whole bloodsamples drawn from the fingertips and palms. Testing is done outsidethe body ( In Vitro diagnostic use). It is indicated for use at home (overthe counter [OTC]) by persons with diabetes, or in clinical settings byhealthcare professionals, as an aid to monitor the effectiveness ofdiabetes control.
Functional andSafety Testing:	A full array of in-house and clinical testing was done consistent withrelevant FDA guidance's for blood glucose monitoring systems.Bench testing included evaluation of interferences, linearity, linearrange, hematocrit effects, altitude effects, control solution functionality,and analytical precision.Clinical testing included evaluation of accuracy for finger stick andpalm test sites.
Conclusion:	Labeling, bench testing results and clinical testing results support theIndications for Use and the claim of substantial equivalence to thepredicate.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Arkray Factory, Inc. c/o Mr. Hamid Idrissi Regulatory Affairs Project Manager 5182 West 76th Street Minneapolis, MN 55439

OCT - 9-2009

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

Re: K090653

Trade Name: PocketChem EZ Meter Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Blood Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: September 14, 2009 Received: September 14, 2009

Dear Mr. Idrissi:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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 Statement (PocketChem EZ) 1

510(k) Number (if known): K 090663

Device Name: PocketChem EZ Meter Blood Glucose Monitoring System

Indications For Use:

PocketChem EZ Blood Glucose Monitoring System:

The PocketChem EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

PocketChem EZ Blood Glucose Meter:

The PocketChem EZ Blood Glucose Meter is intended for the quantitative measurement of qlucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The PocketChem EZ Blood Glucose Meter is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

PocketChem EZ Blood Glucose Test Strips:

PocketChem EZ test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms when used with the PocketChem EZ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The PocketChem EZ Blood Glucose Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Assure Dose CONTROL:

For use with PocketChem EZ Blood Glucose Meter and PocketChem EZ Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Level 1 (Normal) and Level 2 (High).

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C)

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

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

Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Fivaluation and Safety

12191165 4

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.