K Number
K180196
Device Name
On Call Express Mobile Blood Glucose Monitoring System
Date Cleared
2018-03-07

(42 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used 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® Express Mobile 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 Mobile Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
Device Description
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More Information

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No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML development.

No.
The device is used for monitoring blood glucose levels, which aids in managing diabetes, but it does not directly treat or cure the condition. It is for in vitro diagnostic use only.

Yes
The "Intended Use / Indications for Use" states, "It is for in vitro diagnostic use only." and "It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs." This indicates its use in diagnosing and monitoring a medical condition.

No

The device description is not available, but the intended use clearly describes a "Blood Glucose Monitoring System" which typically includes a physical meter and test strips, indicating it is not software-only.

Yes, based on the provided text, the On Call® Express Mobile Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The text explicitly states: "It is for in vitro diagnostic use only."
  • Intended Use: The intended use is for the "quantitative detection of glucose in fresh capillary whole blood." This involves testing a biological sample (blood) outside of the body (in vitro) to diagnose or monitor a condition (diabetes).
  • Test Strips: The description of the test strips further reinforces this by stating they are used for the "quantitative measurement of glucose in capillary blood."

These points clearly align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used 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® Express Mobile 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 Mobile Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.

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

Product codes

NBW

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

fingertip, forearm, palm

Indicated Patient Age Range

Not intended for use on neonates.

Intended User / Care Setting

people with diabetes at home

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 7, 2018

ACON Laboratories, Inc. Oiyi Xie Director, Regulatory Affairs 10125 Mesa Rim Road San Diego, CA 92126

Re: K180196

Trade/Device Name: On Call Express Mobile Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: February 5, 2018 Received: February 6, 2018

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. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

1

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.

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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. J

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

2

Indications for Use

510(k) Number (if known) K180196

Device Name

On Call Express Mobile Blood Glucose Monitoring System

Indications for Use (Describe)

The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used 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® Express Mobile 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 Mobile Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.

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

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)

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