(460 days)
Not Found
No
The description focuses on electrochemical measurement and standard performance metrics, with no mention of AI/ML terms or capabilities.
No
The device measures glucose levels but does not provide therapy or treatment for diabetes; it is an aid to monitor the effectiveness of diabetes control.
No.
Explanation: The "Intended Use" section explicitly states, "The Prodigy Preferred Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use." While it measures glucose, which is a diagnostic tool, the device itself is not intended for the initial diagnosis of a condition. It is for "monitoring the effectiveness of diabetes control" by people already diagnosed with diabetes.
No
The device description explicitly states that the system consists of a meter and test strips, which are hardware components. The summary also details performance studies related to the meter and test strips, further indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Prodigy Preferred Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body. This is the core definition of an in vitro diagnostic test.
- Device Description: The description details the electrochemical method and dry reagent biosensor used to analyze the blood sample, further confirming its function as an IVD.
N/A
Intended Use / Indications for Use
The Prodigy Preferred Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Preferred Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Prodigy Preferred Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The Prodigy Preferred Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The Prodigy Preferred Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Preferred Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, upper arm, palm, calf or thigh
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)
Precision test: According to the test results, the pooled and maximum SD were less than 5.0mg/dL at 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 807.92(c)
SPONSOR
Prodigy Diabetes LLC
Company Address:
Company Name:
2701-A Hutchison McDonald Road Charlotte, NC 28269
Telephone: Fax: Contact Person: 704-285-6400 704-285-6475 Rick Admani
NOV 05 2013
Summary Preparation Date: November 4, 2013
| DEVICE NAME | 807.92(a)(2) |
|---|---|
| Trade Name: | Prodigy® Preferred Blood Glucose Monitoring System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification Name: | System, Test, Blood Glucose, Over the Counter |
| Regulation Number: | 862.1345 |
| Product Code: | NBW, CGA |
| Device Class: | II |
| Panel: | Clinical Chemistry |
PREDICATE DEVICE
807.92(a)(3)
807.92(a)(4)
807.92(a)(1)
| Legally Marketed Equivalent Device | ||
|---|---|---|
| Company | Product | 510(k) # |
| Diagnostic Devices, Inc. | Prodigy Voice BGMS | K073118 |
DEVICE DESCRIPTION
The Prodigy Preferred Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The Prodigy Preferred Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Preferred Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card,
1
Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger.
DEVICE INTENDED USE
807.92(a)(5)
The Prodigy Preferred Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Preferred Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Prodigy Preferred Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.
| Item | Subject device | Predicate Device |
|---|---|---|
| Trade Name | Prodigy Preferred BGMS | Prodigy Voice BGMS |
| Manufacturer | Prodigy Diabetes Care, LLC | Diagnostic Devices, Inc. |
| K Number | K073118 | |
| Similarities | ||
| Indications for | ||
| Use | The Prodigy Preferred Blood Glucose | |
| Monitoring System is intended to be | ||
| used for the quantitative | ||
| measurement of glucose (sugar) in | ||
| fresh capillary whole blood samples | ||
| drawn from the fingertips, forearm, | ||
| upper arm, palm, calf or thigh. The | ||
| Prodigy Preferred Blood Glucose | ||
| Monitoring System is intended to be | ||
| used by a single person and should | ||
| not be shared. |
The Prodigy Preferred Blood Glucose
Monitoring System is intended for
self testing outside the body (in vitro) | The Prodigy Voice Blood Glucose
Monitoring System is intended for use in
the quantitative measurement of
glucose in fresh capillary whole blood
from the finger and the following
alternative sites: the palm, the forearm,
the upper-arm, the calf and the thigh. It
is intended for use by healthcare
professionals and people with diabetes
mellitus at home as an aid in monitoring
the effectiveness of diabetes control
program. It is not intended for the
diagnosis of or screening for diabetes
mellitus.
The alternative site testing in this |
| | | |
| | diagnostic use) by people with
diabetes at home as an aid to
monitor the effectiveness of diabetes
control. The Prodigy Preferred Blood
Glucose Monitoring System should
not be used for the diagnosis of or
screening of diabetes or for neonatal
use. Alternative site testing should
be done only during steady - state
times (when glucose is not changing
rapidly).
The Prodigy No Coding Test Strips
are for use with the Prodigy
Preferred Blood Glucose Meter to
quantitatively measure glucose
(sugar) in fresh capillary whole blood
samples drawn from the fingertips,
forearm, upper arm, palm, calf or
thigh. | system can be used only during
steady-state blood glucose
conditions. |
| Detection
method | Amperometry: measuring a current
produced by a chemical reaction | Amperometry: measuring a current
produced by a chemical reaction |
| Enzyme | Glucose oxidase | Glucose oxidase |
| Test strip
calibration | Code number checking | Code number checking |
| Temperature
compensation | Automatic compensation with built-
in thermister | Automatic compensation with built-
in thermister |
| Sample volume
(µL) | 0.7 µL | 0.7 µL |
| Reaction time
(sec) | 7 | 7 |
| Measurement
range | 20-600 mg/dL | 20-600 mg/dL |
| Operating
condition | 50° F - 104°F (10°C- 40°C), below
85% R.H. (noncondensing) | 50° F - 104°F (10°C- 40°C), between
10% and 85% R.H. (noncondensing) |
| Strip vial
opened use
time | 90 days | 90 days |
| Auto shut off
(min) | 3 | 3 |
| Alarm | Beeping sound and/or error message
in LCD display | Beeping sound and/or error message
in LCD display |
| Communication | RS232 port | RS232 port |
| Differences | | |
| Memory
feature | 120 measurements with day and
time | 450 measurement with day and time |
| Day average | 7-, 14-, 21-, 28- average glucose
result | 7-, 14-, 21-, 28-, 60- and 90 day
average glucose result |
| Speaking
function | no | yes |
| Weight | 2.81 in. (L) x 2.375 in. (W) x 0.75 in.
(H)
71mm (L) x 60mm (W) x 19mm (H) | 3.78 in. (L) x 1.7 in. (W) x 0.71 in. (H)
95mm (L) x 55mm (W) x 18mm (H) |
| Dimension | 1.6 oz with battery | 2.4 ozs |
| | 45 g | 68 g |
| Appearance | Picture / illustration of device | Picture / illustration of device |
Predicate Product Comparison Chart
2
.
3
COMPARISON OF TECHNICAL CHARACTERISTICS
807.92(a)(6)
Prodigy Preferred Blood Glucose Monitoring System has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System (K073118). The Preferred Blood Glucose Monitoring System does not have the Voice capability.
PERFORMANCE TESTING
807.92(b)
Precision test
According to the test results, the pooled and maximum SD were less than 5.0mg/dL at glucose concentration