(181 days)
Not Found
No
The description details a standard electrochemical biosensor system and meter, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies are based on linear regression and accuracy percentages, not metrics typically associated with AI/ML model evaluation.
No
This device is for monitoring glucose levels, not for treating or preventing a disease.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "It is not intended for the diagnosis of or screening for diabetes mellitus". It is instead used as "an aid to monitor the effectiveness of diabetes control."
No
The device description explicitly lists hardware components such as a "hand held meter," "test strip biosensor," "quality control solutions," "lancet," and "lancets." This indicates it is a physical medical device system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative measurement of the concentration of glucose in capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description details a system that uses "biosensor glucose reagent test strip" and a "hand held meter" to analyze a blood sample. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies compare the device's results to other methods (YSI and GLUCOMETER ELITE®) for measuring glucose in blood samples, further confirming its function as an in vitro diagnostic.
- Predicate Device: The mention of a predicate device (GLUCOMETER ELITE Blood Glucose meter) which is also an IVD, supports the classification of this device as an IVD.
The device performs a test on a biological sample (blood) outside of the body to provide information about a physiological state (glucose concentration), which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingerstick
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
people with diabetes at home and/or by healthcare professionals in a clinical setting
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)
Consumer Study:
Linear regression between GlucoPlus™ and YSI for lay users and technician.
Accuracy of lay users compared to YSI using capillary whole blood on 120 specimens at clinical centers: N=120, Y=0.96X-7.90, R=0.985, Sy.x= 12.90, Range=57-481 mg/dL.
Accuracy of technician compared to YSI using capillary whole blood on 120 specimens at clinical centers: N=120, Y=0.95X-6.60, R=0.989, Sy.x=10.75, Range=57-481 mg/dL.
Point of Care Study:
Linear regression between GlucoPlus™ and GLUCOMETER ELITE® for test on department of Home Medical, Internal, and Metabolism.
Home Medical: N=58, Y=1.054X-6.34, R=0.990, Sy.x=11.93, Range=59-341 mg/dL.
Metabolism: N=62, Y= 1.031X-6.06, R=0.986, Sy.x=15.87, Range=56-392 mg/dL.
Internal: N=80, Y=1.046X-4.83, R=0.997, Sy.x=11.98, Range=38-548 mg/dL.
Total: N=200, Y= 1.045X-5.81, R= 0.994, Sy.x=13.30, Range=38-548 mg/dL.
Overall Key Results: The results of the consumer and point of care studies demonstrate good correlation (R>0.98) between ~40 - ~550 mg/dl in capillary whole blood specimens. The regression analysis of the data supports the Substantial Equivalency claim with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System accuracy results:
Glucose concentration
§ 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 the 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
510(k) Number K061234
Sponsor:
GlucoPlus Inc. 2323 Halpern Ville St-Laurent, Quebec Canada H4S 1S3
Contact Information:
Jeffrey Fleishman Official Correspondent 215 815-0897 Fax 215 – 860-1071 Jbf1213@aol.com
Date Prepared: April 25, 2006
Proprietary Name: GlucoPlus™ Blood Glucose Monitoring System
Common Name: Blood Glucose Monitoring System
| Classification Name: | Product Code | Device Class | Regulatory
Numbers |
|--------------------------------------------------------------------------------------------|--------------|--------------|-----------------------|
| Test, Blood Glucose System Over
the Counter | NBW | 2 | 21 CFR 862.1345 |
| Glucose Oxidase | CGA | 2 | |
| Single (Specified) analyte controls
(assayed and unassayed)
Quality Control Material | JJX | 1 | 21 CFR 862.1345 |
Panel: (75) Chemistry
Predicate Device: GLUCOMETER ELITE Blood Glucose meter
Manufacturer: Bayer Corporation
510(k) Number K964630
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1
- Device Description: GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.
Similarities with Predicate Device:
| Feature / Claim | Detail |
|---|---|
| Intended Use | The GlucoplusTM Blood Glucose Test System is comprised |
| of Control Solutions and Test Strip biosensors for use only | |
| with the GlucoplusTM Blood Glucose Meter. It is for | |
| quantitative measurement of the concentration of glucose in | |
| capillary whole blood taken from the fingerstick by people | |
| with diabetes at home and/or by healthcare professionals in | |
| a clinical setting as an aid to monitor the effectiveness of | |
| diabetes control. |
It is not intended for the diagnosis of or screening for
diabetes mellitus, and is not intended for use on neonates. |
| Test Principle | GlucoPlusTM Blood Glucose Monitoring System utilizes a
test strip that contains the enzyme glucose oxidase and a
glucose meter. After the blood is drawn into the test strip,
glucose in the sample reacts with potassium ferricyanide in
the test strip producing potassium ferrocyanide. Potassium
ferrocyanide is produced in proportion to the glucose
concentration in the blood sample. Oxidation of the
potassium ferrocyanide produces an electrical current
which is then converted by the meter to display the glucose
concentration of the blood sample. |
| Warnings and
Precautions | For in vitro diagnostic use. |
| Sample Types | Fresh capillary whole blood samples from a fingerstick. |
| Hematocrit Range | 30 – 55% |
| Power Source | 3 V lithium battery (CR 2032) |
| Battery Use Life | More than 1000 tests |
2
Differences with Predicate Device:
:
| Feature | GlucoPlus TM | Glucometer Elite™ |
|---|---|---|
| Blood Sampling | ||
| Into Strip | Double Sided | |
| (Right or Left) | Sip- in Sampling | |
| Front end only | ||
| Sample Volume | 1.5 µL | 2.0 µL |
| Strip Packaging | 25 Strips stored in a vial | Single strip in foil package. |
| Measuring time | Within 15 seconds | Within 30 seconds |
| Measuring Range | 40 - 600 mg/dL | 20 - 600 mg / dL |
| Measuring Unit | Test results are displayed in | |
| either mg/dl or mmol/L | ||
| depending on the meter setting. | mg/dl or mmol/L | |
| Buttons | 3 Buttons | |
| Center Button: Power | ||
| Left Button: Setting Functions | ||
| Right Button: Memory Functions | No Buttons | |
| Setting Functions | Date, Time, Unit of Measure | None |
| Calibration | Built in Button | Calibration Strip |
| Data Download | Test Results can download by | |
| RS232 or USB interface | N/A | |
| Average Display | Calculate mean results within | |
| 1,7,14,21 and 28 days | Total mean results only. | |
| Control Test Mode | N/A | The Control solution test |
| result will not store into | ||
| memory. | ||
| Flashing Strip | ||
| Symbol | Flashing Strip Symbol will display | |
| when meter is powered on. | N/A | |
| Ready to Test | ||
| Symbol | User can apply blood to strip | |
| after the display on LCD appears | The Function Number (F#) | |
| and the previous test result | ||
| begin flashing alternately. |
3
Data Demonstrating Substantial Equivalence:
The results of the consumer and point of care studies demonstrate good correlation (R>0.98) between ~40 - ~550 mg/dl in capillary whole blood specimens. The regression analysis of the data supports the Substantial Equivalency claim with the predicate device.
Consumer Study
Linear regression between GlucoPlus™ and YSI for lay users and technician
| Accuracy of lay users compared to
YSI using capillary whole blood on
120 specimens at clinical centers | N=120
$Y=0.96X-7.90$
R=0.985
Sy.x= 12.90
Range=57-481 mg/dL |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Accuracy of technician compared to
YSI using capillary whole blood on
120 specimens at clinical centers | N=120
$Y=0.95X-6.60$
R=0.989
Sy.x=10.75
Range=57-481 mg/dL |
Point of Care Study Linear regression between GlucoPlus™ and GLUCOMETER ELITE® for test on department of Home Medical, Internal, and Metabolism
| Home Medical | Metabolism | Internal | Total |
|---|---|---|---|
| N=58 | N=62 | N=80 | N=200 |
| Y=1.054X-6.34 | Y= 1.031X-6.06 | Y=1.046X-4.83 | Y= 1.045X-5.81 |
| R=0.990 | R=0.986 | R=0.997 | R= 0.994 |
| Sy.x=11.93 | Sy.x=15.87 | Sy.x=11.98 | Sy.x=13.30 |
| Range=59-341 mg/dL | Range=56-392 mg/dL | Range=38-548 mg/dL | Range=38-548 mg/dL |
System accuracy results.
| | Glucose concentration