The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs.

The On-Call® Plus 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® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The On-Call® Plus Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and/or 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 provided text describes the "On-Call® Plus Blood Glucose Monitoring System" and its substantial equivalence to a predicate device, the "One Touch Ultra Blood Glucose Monitoring System". The information primarily focuses on non-clinical and clinical performance to establish this equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly mentions compliance with 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" as the primary standard for accuracy requirements. While the document states the device meets these accuracy requirements, it does not provide a direct table detailing the specific accuracy acceptance criteria from ISO 15197:2003 (e.g. percentage of readings within ±15% or ±20% of reference measurements) nor does it report specific performance metrics against these criteria.

However, it does list several performance characteristics that were evaluated:

Feature/Test	Acceptance Criteria (Implicit from ISO 15197:2003, though not explicitly detailed with thresholds)	Reported Device Performance (Summary)
System Accuracy (Clinical Studies)	Meets accuracy requirements per ISO 15197:2003. (Specific thresholds of % within ±X% or ±Y mg/dL not provided in the text).	Non-professional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On-Call® Plus Blood Glucose Monitoring System as compared to results obtained by trained technicians.
Repeatability Precision	Not explicitly stated, implied to meet appropriate precision standards.	Evaluated (details not given).
Intermediate Precision	Not explicitly stated, implied to meet appropriate precision standards.	Evaluated (details not given).
Linearity	Not explicitly stated, implied to meet appropriate linearity standards.	Evaluated (details not given).
Interfering Agents	Not explicitly stated, implied to meet appropriate standards for common interfering substances.	Evaluated (details not given).
Hematocrit Effect	Not explicitly stated, implied to meet appropriate standards for varying hematocrit levels.	Evaluated (details not given).
Temperature Effect (Blood & Control)	Not explicitly stated, implied to meet appropriate standards across operative temperature range.	Evaluated (details not given).
Low Battery Effect	Not explicitly stated, implied to maintain accuracy under low battery conditions.	Evaluated (details not given).
Altitude Effect	Not explicitly stated, implied to maintain accuracy across various altitudes.	Evaluated (details not given).
Sample Volume	Not explicitly stated, implied to perform accurately with specified minimum volume.	Evaluated (details not given).
Software Validation	Not explicitly stated, implied to meet software quality and safety standards.	Evaluated (details not given).
Electromagnetic Compatibility (EMC)	Not explicitly stated, implied to meet relevant EMC standards.	Evaluated (details not given).
Electrical Safety	Not explicitly stated, implied to meet relevant electrical safety standards.	Evaluated (details not given).

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

The text states: "Clinical studies were conducted with lay persons and trained laboratory technicians using the On-Call® Plus Blood Glucose Monitoring System."

Sample Size: The exact sample size for the clinical test set is not provided in the given text.
Data Provenance: The text does not explicitly state the country of origin. It can be inferred that the studies were likely conducted in the US, given the submission is to the FDA and references US regulatory documents. The studies are prospective clinical studies involving both lay persons and trained technicians.

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

Ground Truth Establishment: The ground truth for the clinical studies was established by comparison to the YSI Model 2300 STAT PLUS (K913806). The YSI is a commonly accepted laboratory reference method for glucose measurement.
Number of Experts/Qualifications: The text mentions "trained laboratory technicians" used the predicate device, but it does not specify the number or specific qualifications (e.g., years of experience) of these technicians. The YSI machine itself serves as the reference, not human interpreters in this context.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a blood glucose monitoring system. The accuracy is determined by direct comparison of the device's readings against a laboratory reference standard (YSI Model 2300 STAT PLUS), rather than human adjudication of interpretations.

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

Was one done? No, a MRMC comparative effectiveness study was not done in the context of human readers improving with or without AI assistance. This device is a blood glucose meter, and the comparison is between the device's reading and a laboratory reference, not between human interpretations.
Effect Size of Human Readers with/without AI: Not applicable, as there is no AI component for interpretation by human readers. The clinical study did compare readings obtained by "lay persons" (users at home) to "trained technicians" using the same device, but this isn't a human-reader-with-AI vs. human-reader-without-AI scenario. The conclusion was that lay persons obtained "comparable" readings.

6. Standalone (Algorithm Only) Performance

Was one done? Yes, the entire evaluation of the "On-Call® Plus Blood Glucose Monitoring System" is a standalone performance evaluation of the device as an algorithm/system. The device itself (meter and test strip) is the "algorithm" that measures glucose. Its performance is directly compared to the YSI reference. The clinical study specifically assesses the device's ability to provide accurate readings on its own when used by both lay persons and professionals.

7. Type of Ground Truth Used

The type of ground truth used for the clinical performance evaluation was a laboratory reference method: the YSI Model 2300 STAT PLUS (K913806).

8. Sample Size for the Training Set

The text does not specify the sample size for any training set. Given the time period (2009) and the nature of the device (blood glucose meter), it is highly likely that empirical calibration and validation methods were used rather than a large-scale "training set" in the modern machine learning sense. The "laboratory testing" mentioned (linearity, precision, etc.) would have involved various samples to characterize the device's inherent performance.

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

As discussed above, the concept of a separate "training set" with ground truth in the AI/ML sense is not explicitly presented or likely for this device. The development and calibration of such a device generally involve using reference methods (like YSI) to establish the accuracy of the electrochemical enzymatic assay at various glucose concentrations, across different hematocrit levels, temperatures, etc. This would have involved numerous laboratory samples where the true glucose concentration was known through the reference method. However, the specific details or distinction between "training" and "testing" samples in this context are not provided in the document.

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	k0910057
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Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

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

Date Prepared: January 7, 2009

Contact Person:

Richard Lenart Regulatory Affairs Manager

Proprietary Name of the Device:

On-Call® Plus Blood Glucose Monitoring System

Common Name:

Glucose Test System

Classification Name:

Class II §862.1345 Glucose Test System (To be manufactured and marketed for consumer home and professional use)

Predicate Device:

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

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Proprietary Name	Classification	ProCode	Description	Common Name
On-Call® Plus BloodGlucose MonitoringSystem	862.1345Class II	75 NBW	System, Test,Blood Glucose,Over The Counter	Glucose TestSystem
On-Call® Plus BloodGlucose Meter andOn-Call® Plus BloodGlucose Test Strips	862.1345Class II	75 CGA	Glucose Monitor	Glucose Meter &Test Strips
On-Call® Plus GlucoseControl Solution	862.1660Class I	75 JJX	Single AnalyteControl	Control Solution
On-Call® Plus Lancets andOn-Call® Plus LancingDevice	878.4800Class I	79 FMK	Lancet, Blood	Lancets

Device Name: On-Call® Plus Blood Glucose Monitoring System

Description:

Intended Use:

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Technological Characteristics:

Feature	Specification
Measurement Range	1.1-33.3 mmol/L (20 to 600 mg/dL)
Result Calibration	Plasma-equivalent
Sample	Fresh capillary whole blood
Minimum Sample Size	1 μL
Test Time	10 seconds
Power Source	One (1) CR 2032 3.0V coin cell battery
Battery Life	12 months or approximately 1,000 tests
Glucose Units of Measure	The meter is pre-set at time of manufacturing to either millimoles perliter (mmol/L) or milligrams per deciliter (mg/dL) depending on thecountry of use standard
Memory	Up to 300 records with time and date
Meter Size	85 mm x 54 mm x 20.5 mm
Display Size	35 mm x 32.5 mm
Weight	Approximately 49.5 g (with battery installed)
Operating Temperature	5-45°C (41 - 113°F)
Operating Relative Humidity	20-90% (non-condensing)
Hematocrit Range	30-55%
Data Port	9600 baud, 8 data bits, 1 stop bit, no parity
Sample Site	Fingertip, palm and forearm

Specification of Blood Glucose Meter:

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Comparison to Predicate Devices:

The On-Call® Plus Blood Glucose Monitoring System is substantially equivalent to the One Touch Ultra Blood Glucose Monitoring System, K002134.

Features	On-Call® Plus Blood GlucoseMonitoring System	One Touch Ultra BloodGlucose MonitoringSystem (K002134)
Similarities
Measurement Range	20 to 600 mg/dL (1.1-33.3 mmol/L)	Same
Result Calibration	Plasma-equivalent	Same
Sample	Fresh capillary whole blood	Same
Minimum Sample Size	1 µL	Same
Assay Method	Glucose oxidase biosensor	Same
Power Source	One (1) CR 2032 3.0V coin cell battery	Same
Battery Life	12 months or approximately 1,000 tests	Same
Glucose Units of Measure	mg/dL	Same
Hematocrit Range	30-55%	Same
Automatic Shutoff	Two minutes after last user action	Same
Data Port	One data port	Same
Differences
Test Time	10 seconds	5 seconds
Memory	Up to 300 records with time and date	150 blood glucose and controlsolution tests
Meter Size	85 mm x 54 mm x 20.5 mm	3.12" x 2.25" x 0.85"
Weight	Approximately 49.5 g (with battery installed)	1.5 ounces with battery(Approximately 42 g)
Operating Temperature	5-45°C (41 - 113°F)	6-44°C (43 - 111°F)
Operating Relative Humidity	20-90% (non-condensing)	10-90%
Sample Site	Fingertip, palm and forearm	Fingertip and forearm

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".

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Laboratory Testing:

The performance characteristics of the On-Call® Plus 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, 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® Plus Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On-Call® Plus 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 non-professional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On-Call® Plus 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® Plus Blood Glucose Monitoring System.

Conclusion:

The laboratory testing and clinical study results demonstrate that the On-Call® Plus Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On-Call® Plus Blood Glucose Monitoring System meets the accuracy requirements per 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Acon Laboratories Co. c/o Mr. Richard Lenart 4108 Sorrento Valley Blvd. San Diego, CA 92121

APR - 8 2009

Re: K090057 Trade/Device Name: On-Call Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 07, 2009 Received: January 08, 2009

Dear Mr. Lenart:

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

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indication for Use

510(k) Number (if known): K090057

Device Name: On-Call® Plus Blood Glucose Monitoring System

Indication For Use:

The On-Call® Plus 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® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (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 Diagnostic Device Evaluation and Safety (OVD)

Rute Chelin

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

K090057 510(k)

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.