(230 days)
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No
The summary describes software for data transfer and organization (tables and graphs) from glucose meters, with no mention of AI, ML, or any advanced analytical capabilities beyond basic data presentation.
No
The software is for data transfer and organization from glucose meters and explicitly states it "does not recommend any medical treatment or medication dosage level," thus not directly providing therapy.
No
The software organizes data from glucose meters but explicitly states it "does not recommend any medical treatment or medication dosage level," meaning it does not provide a diagnosis.
Yes
The device is described as "software accessory" and its function is data transfer and organization from glucose meters. There is no mention of any hardware component being part of the device itself.
Based on the provided information, the On Call® Diabetes Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Software's Function: The software's intended use is to transfer, organize, and display data from glucose meters. It does not perform any diagnostic tests itself on a biological sample. It processes data that has already been generated by an IVD (the glucose meter).
- No Diagnostic Output: The description explicitly states that the software "does not recommend any medical treatment or medication dosage level." This further reinforces that its purpose is data management, not providing diagnostic or treatment recommendations based on analysis of a biological sample.
While the software is used in conjunction with IVDs (the glucose meters), it is an accessory for data management and visualization, not an IVD itself.
N/A
Intended Use / Indications for Use
The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.
Product codes
NBW, JOP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
used at home and by health care professionals
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)
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
ACON LABORATORIES, INC. QIYI XIE, M.D. SENIOR STAFF, REGULATORY AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121
Re: K131469
Trade/Device Name: Acon On Call Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: December 05, 2013 Received: December 09, 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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If 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,
Courtney H. Lias -S
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
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Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
On Call® Diabetes Management Software
Indications for Use (Describe)
The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.
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 EDA USE CONLY ONLY . In .. The College .. Same . South .. 1981 .. 1981 .. 1991 .. 1991 .. 1991 .. 1991 .. 1991 .. 1991 .. 199 我的同体要了的都是一些 . - - - - -Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13)