The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, autodisabling lancing devices.

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The On Call" Vivid Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. 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.

The quality control of the On Call Vivid Pro Blood Glucose Monitoring System is performed by testing the test strip on meter with glucose control solution to confirm that the test strip and meter are working together properly. The glucose control solution contains a known concentration of glucose with preservatives in an aqueous based mixture. The control solution test result should fall within the predetermined control solution range for the given strip lot to confirm the accuracy of the On Call Vivid Pro Blood Glucose Monitoring System.

AI/ML Overview

Here's an analysis of the On Call Vivid Pro Blood Glucose Monitoring System's acceptance criteria and the study proving it meets them, based on the provided text:

Acceptance Criteria and Device Performance for On Call Vivid Pro Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document indicates that the device's accuracy was evaluated against the requirements of 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."

The key performance criterion mentioned in the conclusion is "accuracy requirements per EN ISO 15197". While the document doesn't explicitly list the detailed accuracy thresholds from this standard, it states that the system meets these requirements.

Table: Acceptance Criteria (Referenced Standard) and Device Performance (Study Conclusion)

Performance Metric	Acceptance Criteria (from EN ISO 15197:2003)	Reported Device Performance
Accuracy	Meets requirements of EN ISO 15197:2003	Meets the accuracy requirements per EN ISO 15197 and is comparable to a YSI Model 2300 STAT PLUS reference. It demonstrated comparable blood glucose readings between lay persons and trained laboratory technicians.

Note: The specific numerical accuracy criteria (e.g., error grid analysis outcomes, percentage of results within a certain margin of a reference method) for EN ISO 15197:2003 are not provided in this summary but are the underlying benchmark mentioned.

Other performance characteristics evaluated as part of non-clinical tests (though specific acceptance values aren't typically stated as "acceptance criteria" but rather as "specifications" for these types of devices in 510k summaries):

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

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

Sample Size for Clinical Tests: The document states "Clinical studies were conducted with lay persons and trained laboratory technicians". It does not specify the exact number of participants (sample size) for these clinical studies.
Data Provenance: The document does not explicitly state the country of origin of the data. However, as it's a 510(k) submission to the US FDA, and the company is based in San Diego, California, it's highly probable the clinical studies were conducted in the United States. The study is prospective, as it explicitly mentions "Clinical studies were conducted" to evaluate the system's accuracy.

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

Reference Method: The ground truth was established by the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade reference instrument for glucose measurement, widely considered a "gold standard" in blood glucose monitoring studies.
Number of "Experts" for Ground Truth: While the YSI 2300 STAT PLUS is an automated instrument, its operation and validation would typically be performed by trained laboratory technicians. The document implicitly refers to these "trained laboratory technicians" as performing the reference measurements, stating "compared to the YSI Model 2300 STAT PLUS... per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System." The number of these technicians isn't specified, but their qualification is "trained laboratory technicians."

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. The comparison is directly between the result from the On Call Vivid Pro system and the established reference device (YSI Model 2300 STAT PLUS).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a typical MRMC comparative effectiveness study, as understood in the context of radiology or image interpretation where human readers interpret cases with and without AI assistance, was not conducted.
Instead, this study compared the device's performance against a reference standard (YSI Model 2300 STAT PLUS) and evaluated the comparable results between "lay persons" (users of the device) and "trained laboratory technicians" (who often run the reference method). The focus was on the device's accuracy and ease of use for its intended users, not on improving human reader performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the accuracy study comparing the On Call Vivid Pro Blood Glucose Monitoring System to the YSI Model 2300 STAT PLUS effectively represents a standalone performance evaluation of the device.
The device, an electrochemical enzymatic assay, inherently provides an algorithmic output (the glucose reading) based on the electrochemical reaction on the test strip and the meter's calculation. Its performance is assessed independently of further human interpretation or intervention to correct its reading beyond its basic operation. The study evaluated "the system accuracy of the On Call Vivid Pro Blood Glucose Monitoring System."

7. Type of Ground Truth Used

The ground truth used was a reference laboratory instrument's measurement (YSI Model 2300 STAT PLUS). This is a highly accurate and established method for quantifiable analyte measurement.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size or discuss how a training set was used. For a blood glucose monitoring system like this, the "development" or "training" of the system would typically involve extensive engineering, chemical formulation, and calibration efforts during the design phase, rather than a distinct "training set" of patient data as might be seen for AI/ML algorithms that learn from data. The clinical studies described are for validation (test set), not training.

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

Given that a specific "training set" for an AI/ML algorithm isn't described for this device, a method for establishing its ground truth is not applicable in this context. The development of the system's internal algorithms (e.g., for converting electrical current to glucose concentration) would be based on fundamental electrochemical principles, extensive laboratory testing with known glucose concentrations, and calibration against reference methods during the device's engineering and manufacturing process.

Summary

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DEC 1 4 2012

5. 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 K123010

Submitter's Identification:

ACON Laboratories, Inc.

10125 Mesa Rim Road

San Diego, California 92121

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

Date Prepared: December 14, 2012

Contact Person:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs

Proprietary Name of the Device:

On Call Vivid Pro 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

Device Name: On Call Vivid Pro Blood Glucose Monitoring System

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Proprietary Name	Classification	ProductCode	Description	Common Name
On Call® Vivid ProBlood GlucoseMonitoring System	862.1345Class II	75 NBW	System, Test,Blood Glucose,Prescription	Glucose TéstSystem
On Call® Vivid ProBlood GlucoseMeter and On Call®Vivid Pro BloodGlucose Test Strips	862.1345Class II	75 CGA	Glucose Monitor	Glucose Meter &Test Strips
On Call® Vivid ProGlucose ControlSolution	862.1660Class I	75 JJX	Single AnalyteControl	Control Solution

Description:

Intended Use:

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

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The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

Technological Characteristics:

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 µL
Test Time	5 seconds
Power Source	Two (2) CR 2032 3.0V coin cell batteries
Battery Life	Minimum of 1,000 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 500 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)
Operating RelativeHumidity	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" Vivid Pro Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System, K002134.

Features	On Call® Vivid Pro Blood GlucoseMonitoring System	One Touch Ultra Blood GlucoseMonitoring System (K002134)
Similarities
Assay Method	Glucose oxidase biosensor	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
Measurement Range	20 to 600 mg/dL (1.1-33.3 mmol/L)	Same
Automatic Shutoff	Two minutes after last user action	Same
Battery Life	Minimum of 1,000 measurements(without considering data transfer andtest reminder alarms)	1,000 tests
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)
Coding	Auto Coding by meter automaticrecognition of the intended codingafter strip insertion	Manual Coding by manuallyselecting code by pressing button
Meter Memory	Up to 500 records with time and date	150 blood glucose and controlsolution tests
Power Source	Two (2) CR 2032 3.0 V coin cellbatteries	One (1) CR 2032 3.0V coin cellbattery
Meter Size	3.53" x 2.28" x 0.85"(89.6mm x 58mm x 21.7mm)	3.12" x 2.25" x 0.85"
Meter Weight	Approx. 60 g (with battery installed)	1.5 ounces with battery(Approximately 42 g)

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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 Vivid Pro 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 Vivid Pro Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Vivid Pro 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 Vivid Pro 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 "Vivid Pro Blood Glucose Monitoring System.

Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call Vivid Pro Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Vivid Pro 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/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle symbol.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 14, 2012

ACON Laboratories, Inc. c/o Qivi Xie 10125 Mesa Rim Road San Diego, CA 92121

Re: K123010

Trade/Device Name: On Call® Vivid Pro Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: September 26, 2012 Received: September 27, 2012

Dear Qiyi 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 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 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 Part 801); 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 - Qiyi Xie ·

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson for

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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Indications for Use

510(k) Number (if known): K123010

Device Name: On Call® Vivid Pro Blood Glucose Monitoring System

Indications for Use:

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

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 Diagnostics and Radiological Health (OIR)

Kothaus

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123010

Page I of I

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.