(318 days)
No
The device description and performance studies focus on electrochemical detection and standard laboratory and clinical testing, with no mention of AI or ML algorithms.
No.
The device is an in vitro diagnostic device used for monitoring blood glucose levels, not for treating a disease or condition.
Yes
The device is explicitly stated as "intended to be used for the quantitative measurement of glucose... as an aid in monitoring the effectiveness of diabetes control programs," and "It is for in vitro diagnostic use only," which falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components (meter, test strips) and their physical interaction with blood samples to perform the glucose measurement. It is a system that includes both hardware and software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is for in vitro diagnostic use only." and "For In Vitro Diagnostic Use".
- Nature of the Test: The device measures glucose in a biological sample (blood) in vitro (outside the body).
- Purpose: The purpose is to provide quantitative measurement of glucose as an aid in monitoring diabetes control programs. This is a diagnostic purpose, even though it's not for initial diagnosis or screening.
N/A
Intended Use / Indications for Use
The On Call Sharp 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 Sharp 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 Sharp Blood Glucose Monitoring System in not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.
The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm."
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
75 NBW, 75 LFR, 75 JJX
Device Description
The On Call Sharp 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 flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory Testing:
The performance characteristics of the On Call Sharp 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, humidity effect, simulated shipping study - test strip & control solution, control value assignment, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.
Clinical Studies:
Clinical studies were conducted with lay persons and trained laboratory technicians using the On Call Sharp Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Sharp 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 lay persons were able to obtain comparable blood glucose readings when using the On Call Sharp 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 Sharp Blood Glucose Monitoring System.
Conclusion:
The laboratory testing and clinical study results demonstrate that the On Call Sharp Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Sharp Blood Glucose Monitoring System meets the accuracy requirements per EN ISO 15197 and as such is substantially equivalent to the On Call® Vivid Blood Glucose Monitoring System, currently sold on the U.S. market (K112653).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 K130284
Submitter's Identification:
ACON Laboratories, Inc.
10125 Mesa Rim Road
San Diego. California 92121
Tel .: 858-875-8019 Fax: 858-875-8099 Date Prepared: December 12, 2013
Contact Person:
Qiyi Xie Senior Staff, Clinical & Regulatory Affairs
Proprietary Name of the Device:
On Call Sharp Blood Glucose Monitoring System
Common Name:
Glucose Test System
ಡಿ
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
Device Name: On Call Sharp Blood Glucose Monitoring System
| Proprietary Name | Classification | Product
Code | Description | Common Name |
|-----------------------------------------------------|----------------------|-----------------|-------------------------------------------------|------------------------|
| On Call Sharp
Blood Glucose
Monitoring System | 862.1345
Class II | 75 NBW | System, Test,
Blood Glucose,
Prescription | Glucose Test
System |
1
| On Call® Sharp
Blood Glucose
Meter and On Call®
Sharp Blood
Glucose Test Strips | 862.1345
Class II | 75 LFR | Glucose Monitor | Glucose Meter &
Test Strips |
|---------------------------------------------------------------------------------------------|----------------------------------|--------|---------------------------|--------------------------------|
| On Call® Sharp
Glucose Control
Solution | 862.1660
Class I,
reserved | 75 JJX | Single Analyte
Control | Control Solution |
Description:
The On Call Sharp 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 flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry 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.
Intended Use:
The On Call Sharp 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 Sharp 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 Sharp Blood Glucose Monitoring System in not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.
The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm."
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
For In Vitro Diagnostic Use
2
Technological Characteristics:
.
| 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 1,000 measurements (without considering data |
| transfer and test reminder alarms) | |
| Glucose Units of | |
| Measure | The meter is pre-set at time of manufacturing to either millimoles |
| per liter (mmol/L) or milligrams per deciliter (mg/dL) depending | |
| on the standard of your country. The meter will be set to mg/dL | |
| by default when sold in the United States. | |
| Memory | Up to 500 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) |
| Operating | |
| Temperature | 10-45°C (50-113°F) |
| Operating Relative | |
| Humidity | 10-90% (non-condensing) |
| Hematocrit Range | 25-70% |
| Data Port | 9600 baud, 8 data bits, 1 stop bit, no parity |
Specification of Blood Glucose Meter:
3
Comparison to Predicate Devices:
The On Call Sharp Blood Glucose Monitoring System is substantially equivalent to
The On Call Vivid Blood Glucose Monitoring System. K I 12653.
| Features | On Call® Sharp Blood Glucose
Monitoring System | On Call® Vivid Blood Glucose
Monitoring System (K112653) |
|--------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Similarities | | |
| Result Calibration | Plasma-equivalent | Same |
| Test Time | 5 seconds | Same |
| Sample Type | Fresh capillary whole blood | Same |
| Glucose Units of
Measure | mg/dL | Same |
| Operating Relative
Humidity | 10-90% | Same |
| Data Port | One Serial data port | Same |
| Measurement
Range | 20 to 600 mg/dL (1.1-33.3
mmol/L) | Same |
| Automatic Shutoff | Two minutes after last user action | Same |
| Battery Life | Minimum of 1,000 measurements
(without considering data transfer
and test reminder alarms) | Same |
| Minimum Sample
Size | 0.8 µL | Same |
| Coding | Auto Coding by meter automatic
recognition of the intended coding
after strip insertion | Same |
| Meter Memory | Up to 500 records with time and
date | Same |
| Power Source | Two (2) CR 2032 3.0 V coin cell
batteries | Same |
| Meter Size | 3.53" x 2.28" x 0.85"
(89.6mm x 58mm x 21.7mm) | Same |
| Meter Weight | Approx. 60 g (with battery
installed) | Same |
| Differences | | |
| Hematocrit Range | 25-70% | 20-70% |
| Operating
Temperature | 10-45°C (50-113°F) | 5-45°C (41-113°F) |
| Assay Method | FAD-dependent Glucose
Dehydrogenase biosensor | Glucose Oxidase biosensor |
| Meter Display
Backlight | No | Yes |
| Meter Strip Port
Light | No | Yes |
4
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."
Laboratory Testing:
The performance characteristics of the On Call Sharp 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, humidity effect, simulated shipping study - test strip & control solution, control value assignment, meter testing, 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 Sharp Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Sharp 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 lay persons were able to obtain comparable blood glucose readings when using the On Call Sharp 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 Sharp Blood Glucose Monitoring System.
Conclusion:
The laboratory testing and clinical study results demonstrate that the On Call Sharp Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Sharp Blood Glucose Monitoring System meets the accuracy requirements per EN ISO 15197 and as such is substantially equivalent to the On Call® Vivid Blood Glucose Monitoring System, currently sold on the U.S. market (K112653).
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
ACON LABORATORIES, INC. QIYI VIE, M.D., MPH 10125 MESA RIM ROAD SAN DIEGO CA 92121
Re: K130284
Trade/Device Name: On Call Sharp Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: December 18, 2013 Received: December 18, 2013
Dear Dr. Vie:
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.
6
Page 2-Dr. Vie
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/MedicalDeyices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Carol C. Benson -S for
Courtney 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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) k 130284
Davice Name
. •
On Call Sharp Blood Glucose Monitoring System
Indications for Use (Describe)
The On Call Sharp 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 disbetes at home as an aid in monitoring the effectivencss of diabetes control programs. Altemative site testing should be done only daring steady-state times (when blood glucose level is not changing rapidly). The On Call Sharp Blood Gluccee 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 Sharp Blood Glucose Monitoring System in not intended for the diagnosis of or samended for use on neonates.
The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm."
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the lest is performing correctly,
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A BEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CORH) (Signature)
Stavce Beck
FORM FDA 3881 (9/13)
Page 1 of J