The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).

The On Callo Express 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® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

Device Description

The On Call Express 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

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the On Call Express Blood Glucose Monitoring System are based on the EN ISO 15197:2003 standard. The document states that the device "meets the accuracy requirements per EN ISO 15197:2003." Unfortunately, the specific numerical acceptance criteria from EN ISO 15197:2003 and the exact corresponding reported device performance values (e.g., % of results within ±15% or ±20% of reference for specific glucose ranges) are not detailed within the provided text. The text only provides a list of performance characteristics tested.

Therefore, the table below will list the relevant performance characteristics mentioned as being evaluated against the ISO standard in the "Laboratory Testing" section, and indicate that the exact reported performance values are not provided, but that the device meets the ISO standard.

Acceptance Criteria Category (from ISO 15197:2003)	Reported Device Performance (as stated in document)
Repeatability precision	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Intermediate precision	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Accuracy evaluation	Evaluated; device meets accuracy requirements per EN ISO 15197:2003 (compared to YSI Model 2300 STAT PLUS)
User performance	Evaluated (lay persons obtained comparable readings to trained technicians); device meets accuracy requirements per EN ISO 15197:2003
Linearity	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Interfering agents	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Altitude effect	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
System traceability	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Validation of calibration control materials	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Hematocrit effect	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Temperature effect evaluation (blood & control solution)	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Low battery effect evaluation	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Sample volume	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Humidity effect	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Simulated shipping studies (test strip & control solution)	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Accelerated Use Life (control & strip)	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
65° Accelerated Stability (Strip & Control)	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Packaging, vibration, drop tests, temperature exposure, humidity exposure	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Control value assignment	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Virucidal, efficacy validation	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Meter cleaning and disinfection	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Meter testing	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Software validation testing	Evaluated; device meets accuracy requirements per EN ISO 15197:2003
Electromagnetic compatibility and electrical safety testing (per EN/IEC 61010-1 & 61010-2-101)	Evaluated; device meets accuracy requirements per EN ISO 15197:2003

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

Test Set Sample Size: The document does not explicitly state the sample size (number of patients or measurements) for the clinical studies involving lay persons and trained laboratory technicians. It simply mentions "clinical studies were conducted with lay persons and trained laboratory technicians."
Data Provenance: The document does not specify the country of origin for the data. The study involved "lay persons" and "trained technicians" using the device. It is a prospective study as it involved conducting clinical studies and laboratory testing for the device.

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

Number of Experts: One "expert" device was used: the YSI Model 2300 STAT PLUS. The document does not specify a number of human experts involved in establishing the ground truth, but rather refers to readings obtained by "trained technicians."
Qualifications of Experts: The ground truth was established by comparing the On Call Express Blood Glucose Monitoring System's readings to those from the YSI Model 2300 STAT PLUS (K913806), which is a laboratory reference method. The text mentions that "trained technicians" were involved in obtaining readings, implying they are qualified to operate such equipment and conduct these tests accurately. There is no mention of specific medical qualifications (e.g., radiologist with X years of experience) as this is a blood glucose monitoring device.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1 consensus). Instead, the method involved direct comparison of the test device's readings with a recognized laboratory reference method (YSI Model 2300 STAT PLUS). The goal was to establish accuracy by demonstrating concordance, not to resolve discrepancies between multiple human readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This type of study typically involves assessing the performance of multiple human readers on multiple cases, often with and without AI assistance. The study described focuses on the accuracy of the device itself and its usability by lay persons compared to trained technicians using a reference method. It does not evaluate human reader improvement with AI assistance. The device itself is a standalone glucose monitor, not an AI assistant to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was conducted. The "Laboratory Testing" section lists numerous tests (repeatability, precision, accuracy, linearity, interfering agents, etc.) that evaluate the system's performance independently. The "clinical studies" also assess the device's ability to provide accurate blood glucose readings on its own, with lay persons simply operating it according to instructions. The comparison to the YSI Model 2300 STAT PLUS explicitly assesses the algorithm's (and integrated system's) accuracy against a gold standard.

7. The Type of Ground Truth Used

The ground truth used was reference laboratory measurement. Specifically, the On Call Express Blood Glucose Monitoring System's results were compared to those obtained from the YSI Model 2300 STAT PLUS (K913806), which is a widely accepted laboratory reference instrument for glucose measurement.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific training set or its sample size. This device is a blood glucose monitoring system, not a machine learning model that typically undergoes explicit "training" on a separate dataset in the way an AI diagnostic algorithm would. The development and calibration of such devices usually involve internal studies by the manufacturer, but the specific details of these are not disclosed as "training set" information in this 510(k) summary.

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

As no specific "training set" is mentioned in the context of a machine learning model, this question is not directly applicable. For the device's internal calibration and development, it's highly probable that similar reference laboratory methods (like YSI) would have been used, but the document does not elaborate on this.

Summary

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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 K132086 .

Submitter's Identification:

ACON Laboratories, Inc.

10125 Mesa Rim Road

San Diego, California 92121

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

Date Prepared: August 21, 2013

Contact Person:

Oiyi Xic Senior Staff, Clinical & Regulatory Affairs

Proprietary Name of the Device:

40 On Call Express Blood Glucose Monitoring System

Common Name:

Glucose Test System

Classification Name:

Class II §862.1345 Glucose Test System

Predicate Device:

On Call® Vivid Blood Glucose Monitoring System ACON Laboratories, Inc., located at 10125 Mesa Rim Road, CA 92121, USA. 510(k) Number: K112653

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Proprietary Name	Classification	ProductCode	Description	Common Name
On Call ExpressBlood GlucoseMonitoring System	862.1345Class II	75 NBW	System, Test,Blood Glucose,Prescription	Glucose TestSystem
On Call ExpressBlood GlucoseMeter and On Call®Express BloodGlucose Test Strips	862.1345Class II	75 LFR	Glucose Monitor	Glucose Meter &Test Strips
On Call ExpressGlucose ControlSolution	862.1660Class I	75 JJX	Single AnalyteControl	Control Solution

Device Name: On Call Express Blood Glucose Monitoring System

Description:

Intended Use:

The On Call* Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call ' Express 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 * Express Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabctes, nor intended for use on neonates.

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

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The On Call" Express Blood Glucose Control Solution is for use with the On Call" Express Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

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	0.4 µL
Test Time	4 seconds
Power Source	One (1) CR 2032 3.0V coin cell battery
Battery Life	1,000 tests for glucose testing (not considering datatransfer)
Glucose Units ofMeasure	The meter is preset to mg/dL when sold in theUnited States.
Memory	Up to 300 records with time and date
Automatic Shutoff	2 minutes after last action
Meter Size	3.46" x 1.93" x 0.65"
Display Size	1.38" x 1.26"
Weight	Approximately 50 g (with battery installed)
Operating Temperature	41-113°F (5-45°C)
Operating RelativeHumidity	10-90% (non-condensing)
Hematocrit Range	30-55%
Data Port	9600 baud, 8 data bits, 1 stop bit, no parity

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Comparison to Predicate Devices:

The On Call® Express Blood Glucose Monitoring System is substantially equivalent to
The On Call® Vivid Blood Glucose Monitoring System, K112653.

Features	On Call® Vivid Blood GlucoseMonitoring System (K112653)	On Call® Express BloodGlucose Monitoring System
Similarities
Result Calibration	Plasma-equivalent	Same
Sample Type	Fresh capillary whole blood	Same
Assay Method	Glucose oxidase	Same
Glucose Units ofMeasure	mg/dL	Same
Operating RelativeHumidity	10-90%	Same
Data Port	One Serial data port	Same
MeasurementRange	20 to 600 mg/dL (1.1-33.3mmol/L)	Same
Automatic Shutoff	Two minutes after last user action	Same
Battery Life	Minimum of 1,000 measurements(without considering data transferand test reminder alarms)	Same
Coding	Auto Coding by meter automaticrecognition of the intended codingafter strip insertion	Same
Differences
Hematocrit Range	25-70%	30-55%
OperatingTemperature	10-45°C (50-113°F)	41-113°F (5-45°C)
Test Time	5 seconds	4 seconds
Minimum SampleSize	0.8 µL	0.4 uL
Meter Memory	Up to 500 records with time anddate	Up to 300 records with time anddate
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)	3.46" x 1.93" x 0.65"
Meter Weight	Approx. 60 g (with batteryinstalled)	Approx. 50 g (with batteryinstalled)
Meter DisplayBacklight	Yes	No
Meter Strip PortLight	Yes	No

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Discussions 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 tcst 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:

(B) The performance characteristics of the On Call Express Blood Glucose Monitoring System were evaluated by performing the following safety and reliability testing per ISO 15197:2003, Section 6: repeatability precision, intermediate precision, accuracy evaluation, user performance, linearity, interfering agents, , altitude effect, system traceability, validation of calibration control materials, hematocrit effect, tcmperature effect evaluation - blood & control solution, low battery effect evaluation, , sample volume, temperature effect evaluation (blood and control solution), humidity offect, simulated shipping studies - test strip & control solution, accelerated Use Life (control & strip), 65° Accelerated Stability (Strip & Control), packaging, vibration, drop tests, temperature exposure, and humidity exposure, control value assignment, virucidal, efficacy validation, meter cleaning and disinfection, meter testing, software validation testing, electromagnetic compatibility and clectrical safety testing (per EN/IEC 61010-1 & 61010-2-101) 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 Express Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Express 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 lau persons were able to obtain comparable blood glucose readings when using the On Call Express Blood Glucose Monitoring System as compared to the results obtained by the trained tcchnicians. 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 Express Blood Glucosc Monitoring System.

Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call Express Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On

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Call Express Blood Glucose Monitoring System mets the accuracy requirements per EN ISO
I S197:2003 and as such is substantially equivalent to the On Call® Vivi Monitoring System, currently sold on the U.S. market (K 1 12653).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2013

ACON LABORATORIES, INC. QIYI XIE, M.D., MPH SR. STAFF (RA/CA) 10125 MESA RIM ROAD SAN DIEGO CA 92121

Re: K132086

Trade/Device Name: On Call Express Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: November 05, 2013 Received: November 06, 2013

Dear Dr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Parts 801 and 809); 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-Dr. Xie

1f you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carol G. Benson -S 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132086

Device Name

On Call® Express Blood Glucose Monitoring System

Indications for Use (Describe)

The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearn and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).

The On Callo Express 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/8/Picture/16 description: The image shows the name "StayceBeck" in a bold, sans-serif font. The text appears to be slightly distressed, with some areas showing signs of wear or damage, giving it a textured look. The letters are large and clearly legible, making the name easily readable.

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.