(210 days)
Not Found
No
The description details a standard electrochemical enzymatic assay for glucose measurement, with no mention of AI or ML algorithms for data processing, interpretation, or prediction.
No.
The device is for monitoring glucose levels, which aids in managing diabetes, but it does not directly treat or cure the condition. It's an in vitro diagnostic device used for measurement, not therapy.
Yes
The document explicitly states, "The On Call® Vivid Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood... as an aid in monitoring the effectiveness of diabetes control programs." This indicates its use in providing information for medical management, which is the definition of a diagnostic device.
No
The device description explicitly mentions a "meter" and "test strip" which are hardware components essential for the device's function. The system relies on an electrochemical enzymatic assay and amperometric detection, which are physical processes involving hardware.
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."
- Nature of the Test: The device performs a quantitative measurement of glucose in a biological sample (blood) outside of the body. This is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control programs, which is a diagnostic purpose.
N/A
Intended Use / Indications for 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. 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.
- · 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
Product codes (comma separated list FDA assigned to the subject device)
75 NBW, 75 CGA, 75 JJX, 79 FMK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, forearm, palm
Indicated Patient Age Range
Not Found
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)
Not Found
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.
Not Found
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
§ 862.1660 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.
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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 | Product
Code | Description | Common Name |
|---------------------------------------------------------------------------------------------|----------------------|-----------------|-----------------------------------------------------|--------------------------------|
| On Call® Vivid
Blood Glucose
Monitoring System | 862.1345
Class II | 75 NBW | System, Test,
Blood Glucose,
Over The Counter | Glucose Test
System |
| On Call® Vivid
Blood Glucose
Meter and On Call®
Vivid Blood
Glucose Test Strips | 862.1345
Class II | 75 CGA | Glucose Monitor | Glucose Meter &
Test Strips |
| On Call® Vivid
Glucose Control
Solution | 862.1660
Class I | 75 JJX | Single Analyte
Control | Control Solution |
| On Call® Lancets
and On Call®
Lancing Device | 878.4800
Class I | 79 FMK | Lancet, Blood | Lancets |
Device Name: On Call Vivid Blood Glucose Monitoring System
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.
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:
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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 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 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) |
| Operating | |
| Temperature | 5-45°C (41-113°F) |
| Operating | |
| RelativeHumidity | 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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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
5
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 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.
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