The On Call® Chosen Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Chosen Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

The On Call Chosen Blood Glucose Control Solution is for use with the On Call Chosen Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

The On Call "Chosen Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

AI/ML Overview

This document describes the acceptance criteria and the study performed for the On Call Chosen Blood Glucose Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The submission references compliance with EN ISO 15197:2003 for accuracy requirements. Based on the "Discussion of Clinical Tests Performed" section, it states that the system meets these accuracy requirements. No specific performance metrics (e.g., bias, CV, or percentages within zones of an error grid) are numerically presented in the provided text as 'acceptance criteria' vs. 'reported performance' in a direct comparison table. However, the overall conclusion states that the device meets the accuracy requirements per EN ISO 15197.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies were conducted with lay persons and trained laboratory technicians," but does not provide the number of participants or samples collected.
Data Provenance: Not explicitly stated. Given ACON Laboratories, Inc. is located in San Diego, California, it's likely the studies were conducted in the US, but this is not confirmed. The study was conducted according to the "ACON Clinical Study Protocol for the Blood Glucose Monitoring System," implying a prospective study design.

3. 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)

Number of Experts/Ground Truth Method: The reference method for establishing ground truth was the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade analyzer for glucose measurement, not an expert human assessment.
Qualifications of Experts: Not applicable, as the ground truth was established by an analytical instrument. However, the study involved "trained laboratory technicians" who operated the YSI device, implying they were qualified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. The ground truth was established by a reference instrument (YSI Model 2300 STAT PLUS). No human adjudication process is mentioned for the reference method.

5. 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

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a blood glucose monitoring system, and the study focused on its accuracy compared to an established laboratory reference, and ease of use by lay persons, rather than assessing improvements in human reader performance with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, in essence, the "system accuracy" evaluation of the On Call Chosen Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS constitutes a standalone performance evaluation of the device itself (though humans are involved in using both systems). The study specifically aimed to show that "nonprofessional, inexperienced lay persons were able to obtain comparable blood glucose readings" to those obtained by trained technicians using the reference, implying the device's inherent accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The ground truth was established using a reference laboratory instrument, specifically the YSI Model 2300 STAT PLUS (K913806).

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is a blood glucose monitoring system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The studies performed were for verification and validation of the device's performance, not for training an algorithm.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device mentioned.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The Assigned 510(k) number is K111371 - .

Submitter's Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121

Tel.: 858-875-8019 Fax: 858-875-8099

Date Prepared: May 14, 2011

Contact Person:

Oivi Xie Senior Staff, Clinical & Regulatory Affairs

Proprietary Name of the Device:

On Call Chosen Blood Glucose Monitoring System

Common Name:

Glucose Test System

Classification Name:

Class II §862.1345 Glucose Test System

Predicate Device:

One Touch Ultra Blood Glucose Monitoring System Lifescan, Inc., located at 1000 Gibraltar Dr., Milpitas, CA 95035, USA. 510(k) Number: K002134

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Proprietary Name	Classification	ProductCode	Description	Common Name
On Call® ChosenBlood GlucoseMonitoring System	862.1345Class II	75 NBW	System, Test,Blood Glucose,Over The Counter	Glucose TestSystem
On Call® ChosenBlood GlucoseMeter and On Call®Chosen BloodGlucose Test Strips	862.1345Class II	75 CGA	Glucose Monitor	Glucose Meter &Test Strips
On Call® ChosenGlucose ControlSolution	862.1660Class I	75 JJX	Single AnalyteControl	Control Solution

Device Name: On Call Chosen Blood Glucose Monitoring System

Description:

Intended Use:

The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

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Technological Characteristics:

く

Specification of Blood Glucose Meter:

Feature	Specification
Measurement Range	20 to 600 mg/dL (1.1-33.3 mmol/L)
Result Calibration	Plasma-equivalent
Sample	Fresh capillary whole blood
Minimum Sample Size	0.8 uL
Test Time	5 seconds
Power Source	Two (2) CR 2032 3.0V coin cell batteries
Battery Life	Minimum of 3,000 measurements (without considering datatransfer and test reminder alarms)
Glucose Units ofMeasure	The meter is pre-set at time of manufacturing to eithermillimoles per liter (mmol/L) or milligrams per deciliter(mg/dL) depending on the standard of your country. The meterwill be set to mg/dL by default when sold in the United States.
Memory	Up to 300 records with time and date
Meter Size	3.58" x 2.28" x 0.83"
Display Size	1.58" x 1.42"
Weight	Approximately 60 g (without battery installed)
OperatingTemperature	5-45°C (41-113°F)
OperatingRelativeHumidity	10-90% (non-condensing)
Hematocrit Range	20-70%
Data Port	9600 baud, 8 data bits, 1 stop bit, no parity

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Comparison to Predicate Devices:

The On Call" Chosen Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System, K002134.

Features	On Call® Chosen Blood GlucoseMonitoring System	One Touch Ultra BloodGlucose Monitoring System(K002134)
Similarities
Assay Method	Glucose oxidase biosensor	Same
Strip ChemicalComposition		Same
Result Calibration	Plasma-equivalent	Same
Test Time	5 seconds	Same
Sample Type	Fresh capillary whole blood	Same
Glucose Units ofMeasure	mg/dL	Same
Operating RelativeHumidity	10-90%	Same
Data Port	One Serial data port	Same
Automatic Shutoff	Two minutes after last user action	Same
Measurement Range	20 to 600 mg/dL (1.1-33.3 mmol/L)	Same
Differences
Minimum SampleSize	0.8 µL	1.0 µL
Hematocrit Range	20-70%	30-55%
OperatingTemperature	5-45°C (41-113°F)	6-44°C (43-111°F)
Alternative SampleSite for Capillary	Palm and forearm in addition tofingertip	Fingertip and forearm
Meter Memory	Up to 300 records with time and date	150 blood glucose and controlsolution tests
Battery Life	Minimum of 3,000 measurements(without considering data transfer andtest reminder alarms)	1,000 tests
Power Source	Two (2) CR 2032 3.0V coin cellbatteries	One (1) CR 2032 3.0V coin cellbattery
Meter Size	3.58" x 2.28" x 0.83"	3.12" x 2.25" x 0.85"
Meter Weight	Approx. 60 g (without batteryinstalled)	1.5 ounces with battery(Approximately 42 g)

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The On Call " Chosen Blood Glucose Monitoring System Control Solution is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System Control Solution, K002134.

Features	On Call® Chosen Blood GlucoseMonitoring SystemControl Solution	One Touch Ultra Blood GlucoseMonitoring System ControlSolution (K002134)
Intended Use	On Call® Chosen Control Solutioncontains a known concentration ofglucose and it is used to confirm thetest strips and the blood glucose meterare working together properly andthat you are performing the testcorrectly.	To check that the meter and teststrips are working together as asystem and that you areperforming the test correctly. It isvery important that you do controlsolution tests routinely to makesure you are getting accurateresults.
Format	Liquid solutionOn Call® Chosen Control solution 1has less than 0.2% glucose (activeingredient). Control Solution 2 hasless than 0.4% glucose (activeingredient). Both solutions havepreservatives in water based mixture.	Liquid solutionOneTouch® Ultra™ ControlSolution is a red solution thatcontains about 0.11% D-glucose.It also contains: Sodium benzoate0.2%; Disodium EDTA 0.1%;FD&C red Dye 0.2%;Viscosity-adjusting agent 8.0%
Stability	6 Months after first opening	3 Months after first opening

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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Guidance documents included the "FDA Guidance for Industry In Vitro Diagnostic Glucose Test System" and "FDA Guidance for Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems" as well as "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Compliance to applicable voluntary standards includes EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."

Laboratory Testing:

The performance characteristics of the On Call Chosen Blood Glucose Monitoring System were evaluated by performing the following studies: repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, control value assignment, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.

Discussion of Clinical Tests Performed:

Clinical studies were conducted with lay persons and trained laboratory technicians using the On Call Chosen Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Chosen Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS (K913806) per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System. Study results indicate that nonprofessional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On Call Chosen Blood Glucose Monitoring System as compared to the results obtained by the trained technicians. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the On Call Chosen Blood Glucose Monitoring System.

Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call Chosen Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Chosen Blood Glucose Monitoring System meets the accuracy requirements per EN ISO 15197 and as such is substantially equivalent to the One Touch Ultra Blood Glucose Monitoring System, currently sold on the U.S. market (K002134).

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with outstretched wings, which is a common symbol associated with the department.

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

Acon Laboratories Inc. c/o Mr. Qiyi Xie Sr. Staff Regulatory/Clinical Affairs 10125 Mesa Rim Rd., San Diego, CA 92121

OCT - 6 2011

રિણ: K111371

Trade Name: On-Call Chosen Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: September 21, 2011 Received: September 22, 2011

Dear Mr. Xie:

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 approvat 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 ther 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) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro 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 reportine 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/MedicalDevicesforYou/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 Form

510(k) Number (if known):

Device Name: On Call Chosen Blood Glucose Monitoring System

Indications for Use:

The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

Prescription Use (Part 21 CFR 801 Subpart D)

V Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

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

CARS

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

510(k)	k11137
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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.