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

The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use.

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

The On Call® Vivid Blood Glucose Control Solution is for use with the On Call® Vivid Blood Glucose Meter and Test 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 Vivid 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 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

The On Call Vivid Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, forearm, and palm.

Here's an analysis of the provided text regarding its acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to CLSI POCT12-A3 as the standard for accuracy. CLSI POCT12-A3 outlines specific accuracy criteria for point-of-care blood glucose meters. The document states that the testing demonstrated that the "On Call Vivid Blood Glucose Monitoring System meets the accuracy requirement of CLSI POCT12-A3," but it does not explicitly list the specific criteria from CLSI POCT12-A3 or the detailed reported device performance against those criteria in a table format within the provided text.

However, it does provide a summary of accuracy with reference to the laboratory reference method:

Concentration Range (mg/dL)	Clinical Study Accuracy (On Call Vivid vs. Reference Method)
≤ 75 mg/dL	100% of results within ± 15 mg/dL
> 75 mg/dL	100% of results within ± 20%
All Concentrations Combined
Within ± 15 mg/dL or ± 15%	98.7%
Within ± 15 mg/dL or ± 20%	100%

The document also further states the system achieved:

Repeatability Study: SD of 2.1 mg/dL for 46 mg/dL, and CV of 2.7–3.0% for 100-300 mg/dL.
Intermediate Precision Study: SD of 2.2 mg/dL for 46 mg/dL, and CV of 3.4–3.5% for 100-330 mg/dL.

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

The document states multiple studies were conducted:

Clinical Study (Accuracy, Fingertip): 400 subjects. The provenance is not explicitly stated (e.g., country of origin) but it is a "clinical study," which typically implies prospective data collection from human subjects.
Clinical Study (Accuracy, Alternative Sites - Forearm and Palm): 100 subjects for each alternative site (forearm and palm). The provenance is not explicitly stated.
Interference Study: 18 interfering substances tested.
Hematocrit Study: Demonstrated acceptable performance across a hematocrit range of 20-70%.
Repeatability Study: 10 samples tested 10 times for a total of 100 measurements.
Intermediate Precision Study: 10 samples tested on 10 different days/times for a total of 100 measurements.

All studies appear to be prospective as they describe testing performed with the device. The country of origin for the data is not specified in the provided text.

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

The document states that the ground truth for the clinical studies was established using a "YSI 2300 STAT Plus Glucose Analyzer" as the laboratory reference method.

No human experts were used to establish the primary ground truth. The YSI 2300 STAT Plus Glucose Analyzer is a widely accepted laboratory instrument for glucose measurement, acting as the verifiable reference.

4. Adjudication Method for the Test Set:

No adjudication method is relevant as the ground truth was established by an objective laboratory reference instrument (YSI 2300 STAT Plus Glucose Analyzer), not by human expert consensus that would require adjudication.

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

No MRMC comparative effectiveness study was done or reported. This device is a blood glucose monitoring system, and its performance is typically evaluated against laboratory reference methods, not by comparing human reader performance with and without AI assistance. The concept of "human readers" in the context of interpreting results from this device is not directly applicable in the same way as, for example, image interpretation in radiology.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Yes, a standalone study was done. The described clinical studies and performance evaluations (accuracy, precision, interference, hematocrit) assess the device's performance independently against a reference standard. The "On Call Vivid Blood Glucose Monitoring System" itself produces the glucose reading, and its accuracy is measured directly. Human involvement is in operating the device and collecting the sample, but the measurement and calculation are done by the device's inherent algorithms.

7. Type of Ground Truth Used:

The primary ground truth used for the accuracy studies was objective laboratory reference measurement by a YSI 2300 STAT Plus Glucose Analyzer.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size for a "training set." For devices like blood glucose meters, the "training" usually refers to the development and calibration of the electrochemical system and algorithms, which is typically done internally by the manufacturer with extensive internal testing. The provided data focuses on the validation (test set) of the final device. It's unlikely that "training set" in the machine learning sense is relevant or would be disclosed in this type of submission.

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

As mentioned above, the concept of a distinct "training set" with established ground truth for this type of device is not detailed in the document. The development and calibration of the device would involve rigorous internal testing against laboratory reference methods (similar to the YSI 2300 STAT Plus Glucose Analyzer) during the design and engineering phases to ensure the device outputs accurate glucose readings.

Summary

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K112653

APR - 9 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 _ _ _ _ _ ______________________________________________________________________________________________________________________________________

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:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs

Proprietary Name of the Device:

On Call" Vivid 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® VividBlood GlucoseMonitoring System	862.1345Class II	75 NBW	System, Test,Blood Glucose,Over The Counter	Glucose TestSystem
On Call® VividBlood GlucoseMeter and On Call®Vivid BloodGlucose Test Strips	862.1345Class II	75 CGA	Glucose Monitor	Glucose Meter &Test Strips
On Call® VividGlucose ControlSolution	862.1660Class I	75 JJX	Single AnalyteControl	Control Solution
On Call® Lancetsand On Call®Lancing Device	878.4800Class I	79 FMK	Lancet, Blood	Lancets

Device Name: On Call Vivid Blood Glucose Monitoring System

Description:

Intended Use:

The On Call® Vivid Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Fingertip, forearm and palm testing sites should be used alternately only when blood glucose level is not changing rapidly. The On Call® Vivid 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.

· This device is not indicated for the diagnosis or screening of diabetes.
· Alternative site testing can be used only during steady-state blood glucose conditions.
· Alternative site testing (AST) should not be used to calibrate continuous glucose monitors (CGMs) nor for use in insulin dose calculations.
· The On Call Vivid Blood Glucose Meter and Strips are to be used with the On Call Vivid Blood Glucose Monitoring System; it measures glucose in capillary whole blood from the fingertip, forearm and palm.
· For In Vitro Diagnostic Use

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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 3,000 measurements (without considering data transfer 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a human figure with three arms or wings extending upwards.

Public Health Service

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

Acon Laboratories, Inc. c/o Qiyi Xie 10125 Mesa Rim Rd. San Diego, CA 92121

K112653 Re:

APR - 9 2012

KT12055
Trade Name: On Call Vivid Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CGA, NBW, JJX Dated: March 17, 2012 Received: March 19, 2012

Dear Dr. Xie:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave leviewed your Section STO(s) promised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enclosers, to teenactment date of the Medical Device interstate commerce prior to May 20, 1970, cases as the est receives approval of a premarket Amendments, or to devices that have been reculties that require approval of a premaint the Federal Food, Drug, and Costient Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the ge approval application (f MA). Tou may, increase of the Act include controls provisions of the Act. The gential of devices, good manufacturing practice, increases for labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III If your device is classified (ec above) into controls. Existing major regulations affecting (PMA), it may be subject to Such adultional Collections (CFR), Patis 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 800 your device can be found in Title ZT, Code of Pederal Regulation (1 - 1)
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 Please be advised that FDA s Issualite of a substitives with other requirements
mean that FDA has made a determination that your devices with other Federal agencies, mean that FDA has made a delemination that your and regulations by other Federal agencies.
of the Act or any Federal statutes and regulations and regulations gencies. of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act's requirements, including, but not ical device You must comply with an the Act 3 requirently and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFK Part 807), labeling (21 Creates events) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); and good reporting (reporting of medical device-related adverse evensy (2008) 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 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/Medical

Devices/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/ResourcesforYou/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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): _ 510(k) Number (if known): _ 5 10(k) Number (if known): 3 5 2

Device Name:

On Call® Vivid Blood Glucose Monitoring System

The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

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

Signature

Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) 12112653

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.