PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K122338 |
|---|---|
| Device Name | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | Prodigy Diabetes Care, LLC |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Nov 5, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 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.
Device Story
System comprises handheld meter and dry reagent biosensor test strips (glucose oxidase). User applies fresh capillary whole blood sample (min 0.7 µL) to test strip; meter performs electrochemical measurement (amperometry). Current magnitude is proportional to glucose concentration. Device features automatic temperature compensation via thermistor. Results displayed on LCD; stored in internal memory (120 measurements). Data exportable via RS232 port. Used by patients at home for self-monitoring. Healthcare providers use output to assess diabetes control effectiveness. System includes cleaning/disinfection protocols for single-patient use.
Clinical Evidence
Clinical performance evaluated via lay user study (n=150) and healthcare professional study (n=100). Accuracy compared against YSI 2300 reference method across multiple body sites (finger, palm, forearm, upper arm, calf, thigh). Results met ISO 15197:2003 criteria: 95% of results <75 mg/dL within ±15 mg/dL and ≥75 mg/dL within ±20% of reference. Bench testing confirmed linearity (20-600 mg/dL), precision (CV 2.5-5.5%), and lack of interference from 24 common substances.
Technological Characteristics
Electrochemical biosensor; glucose oxidase enzyme; amperometric sensing; automatic temperature compensation via thermistor; 0.7 µL sample volume; 7-second reaction time; 20-600 mg/dL range; RS232 connectivity; battery-powered; LCD display; 90-day strip vial stability; 20-60% hematocrit range.
Indications for Use
Indicated for quantitative blood glucose measurement in people with diabetes mellitus for home monitoring of diabetes control. Suitable for capillary whole blood from fingertips, forearm, palm, calf, or thigh. Contraindicated for neonatal use, diabetes diagnosis, or screening. Alternative site testing restricted to steady-state glucose conditions.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Prodigy Voice Blood Glucose Monitoring System (k073118)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k122338
B. Purpose for Submission:
New Device
C. Measurand:
Capillary whole blood glucose
D. Type of Test:
Quantitative, Amperometric method, Glucose oxidase
E. Applicant:
Prodigy® Diabetes Care LLC
F. Proprietary and Established Names:
Prodigy® Preferred Blood Glucose Monitoring System
G. Regulatory Information:
| Device | Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| Preferred Blood Glucose Monitoring System | NBW, CGA (over the counter) | Class II | 21 CFR § 862.1345, glucose test system, over the counter, Glucose oxidase | 75-Chemistry |
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
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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.
3. Special conditions for use statement(s):
For in vitro diagnostic use.
Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state.
Severe dehydration and excessive water loss may cause false low results.
Never chew or swallow a test strip.
All parts of this kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
These devices are intended to be used for patient self-monitoring and should not be used to collect blood from more than one person as this poses a risk of transmitting bloodborne pathogens such as Hepatitis B or HIV.
Prodigy Preferred Meter should not be used for calibrating CGMs or for insulin dosing calculations.
Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
4. Special instrument requirements:
Preferred Blood Glucose Meter to be used with the Prodigy No Coding Test Strips.
I. Device Description:
The Prodigy Preferred Blood Glucose Monitoring System consists of a meter and 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 Control Solutions (levels, low and high)
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were previously cleared under 510(k) submission k073118). Level Low is included with the Prodigy Preferred BGMS. The two control solutions can be purchased separately.
# J. Substantial Equivalence Information:
1. Predicate device name(s): Prodigy Voice Blood Glucose Monitoring System
2. Predicate 510(k) number(s): k073118
3. Comparison with predicate:
The Preferred Blood Glucose Monitoring System has the following similarities and differences to the predicate device:
| Items | Predicate Device | Candidate Devices |
| --- | --- | --- |
| Brand Name | Prodigy Voice Blood Glucose Monitoring System (k073118) | Prodigy Preferred Blood Glucose Monitoring System (k122338) |
| Indications for Use | The Prodigy Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood as an aid in monitoring the effectiveness of diabetes control program. | Same |
| Speaking function | Yes | No |
| Enzyme | Glucose Oxidase | Same |
| Detection method | Amperometric method | Same |
| Battery life | Over 1000 tests | Same |
| Power | Two 1.5V AAA alkaline batteries | One 3V CR2032 batteries |
| Auto turn-off | After 3 minutes without action | Same |
| Test range | 20 mg/dL to 600 mg/dL | Same |
| Operating conditions | 50°F to 104°F (10°C to 40°C), below 85% R.H. (non-condensing) | Same |
| Storage/Trans- portation conditions | 39.2 to 115 °F (4 to 46 °C), below 85% R.H | Same |
| External | USB Data port | Data port (non-USB) |
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| Items | Predicate Device | Candidate Devices |
| --- | --- | --- |
| Brand Name | Prodigy Voice Blood Glucose Monitoring System (k073118) | Prodigy Preferred Blood Glucose Monitoring System (k122338) |
| output | | |
| Weight | 68g (2.4 oz) with batteries | 45g (1.6 oz) with batteries |
| Dimension | 95 mm (L) x 55 mm (W) x 18 mm (H) | 71 mm (L) x 60 mm (W) x 19 mm (H) |
| Memory | 450 measurements with date and time | 120 measurements with date and time |
| Day average | 7-, 14-, 21-, 28-, 60- and 90 day average glucose result | 7-, 14-, 21- and 28 day average glucose result |
| Glucose units | Either mg/dL or mmol/L | Same |
| Test strip | Code number checking | Same |
| Temperature compensation | Automatic compensation with built-in thermister | Same |
| Sample volume | 0.7 μl | Same |
| Reaction time | 7 seconds | Same |
K. Standard/Guidance Document Referenced (if applicable):
IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance EMC
ISO 14971 Application of risk management to medical devices
ISO 15197 In vitro diagnostic test systems – Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
EP5-A: Evaluation of precision performance of clinical chemistry devices
EP9-A2: Method comparison and bias estimation using patient samples; approved guideline
L. Test Principle:
The Preferred Blood Glucose Monitoring System uses an electrochemical method. It is based on the quantitative measurement of glucose in whole blood using amperometric method, which detects the current produced from glucose oxidation. Glucose in the sample mixes with specific chemicals on the test strip producing a small amount of electrical current. The meter measures the current and displays the corresponding blood glucose level in the sample. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
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The repeatability study was performed by a single operator in one day using lithium heparin anti-coagulated venous whole blood at five different glucose concentrations. The final glucose concentrations for the blood sample were confirmed by YSI 2300. Each sample was tested ten times on ten meters using three lots of test strips (each meter tested with three test strips lots). Thirty measurements were obtained per meter and three test strip lots, and a glucose concentration $(\mathrm{N} = 300$ per concentration level). The results are summarized below:
Repeatability summary
| Glucose Concentrations (mg/dL) | 30 to 50 | 51 to 110 | 111 to 150 | 151 to 250 | 251 to 400 |
| --- | --- | --- | --- | --- | --- |
| YSI (mg/dL) | 42.3 | 79.8 | 132 | 198 | 325 |
| Overall mean (mg/dL) | 42.4 | 78.5 | 134.3 | 195.4 | 329.4 |
| Overall SD (mg/dL) | 2.3 | 2.7 | 3.4 | 5.0 | 9.2 |
| Overall CV (%) | 5.5 | 3.4 | 2.5 | 2.6 | 2.8 |
Intermediate precision studies were performed by a single operator using three levels of control solutions. Each sample was tested ten times on ten meters using three lots of test strips for ten days (N=1000 per concentration level).
Intermediate Precision summary
| Control Solutions | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- |
| YSI (mg/dL) | 40.8 | 121 | 351 |
| Overall mean (mg/dL) | 40 | 120 | 350 |
| Overall SD (mg/dL) | 2.0 | 4.1 | 9.9 |
| Overall CV (%) | 5.0 | 3.4 | 2.8 |
# b. Linearity/assay reportable range:
Thirteen lithium heparin anti-coagulated venous whole blood samples were prepared to cover the device measuring range. Glucose concentrations (15.1, 21.1, 50.3, 90.8, 150, 248, 305, 352, 401, 457, 505, 601 and $621\mathrm{mg / dL}$ ) were confirmed by the YSI 2300 glucose analyzer. The study was performed using ten meters and three lots of test strip in replicates of ten per meter $(N = 103$ per test strip lot). The results are summarized below:
| Strip lot | N | R2 | Linear Regression |
| --- | --- | --- | --- |
| 1 | 103 | 0.9980 | y=0.9757x+4.1230 |
| 2 | 103 | 0.9979 | y=0.9702x+4.9569 |
| 3 | 103 | 0.9980 | y=0.9810x+3.1466 |
| combined | 309 | 0.9980 | y=0.9822x+2.8123 |
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The measurement range of the Preferred Blood Glucose Monitoring Systems is 20 to 600 mg/dL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The Preferred Blood Glucose Monitoring System is traceable to NIST SRM#917b Clinical Dextrose standard.
**Prodigy Control Solutions:** The Prodigy Control Solutions were cleared under k073118. Please see k073118 for traceability, stability, and expected value information. The shelf life of Prodigy Control Solutions is 18 months for closed vials, and 90 days after a vial has been opened when stored tightly closed at temperatures between 39°F to 86°F (4°C to 30°C), and between 10% to 90% R.H.
**Prodigy Test Strip Stability** - The Prodigy No Coding Test Strips were cleared under k073118. The Stability study protocol and acceptance criteria for opened and closed vial stability provided supports the stability claims of 24 months shelf-life for unopened test strip vials, and of 3 months after opening when stored at temperatures between 39.2°F to 104°F (4°C to 40°C) and at humidity conditions between 10% to 85% R.H.
d. Detection limit:
The reportable range is 20 to 600 mg/dL based on the linearity/assay reportable range study above (section M.1.b).
e. Analytical specificity:
Interference study was designed according to CLSI EP7-A2 guideline.
Twenty four potential endogenous and exogenous interfering substances were evaluated by spiking lithium heparin anti-coagulated venous whole blood with three levels of glucose concentrations within the ranges 50 – 100, 200 – 275 and 400 – 500 mg/dL (measured by YSI). The blood samples were spiked with the potentially interfering compounds and tested on five meters using three test strip lots. Several concentrations of the interfering substances were tested. The interferent concentrations tested in this study were higher than the therapeutic and toxic levels. Bias was calculated as the individual percent difference in glucose reading between the test (individual measurements) and control (mean value) concentration groups. Significant interference is defined by the sponsor as a bias ≥ ±10% of the test samples from the control group.
The sponsor claims no significant interference (< 10% difference) for the substances and concentrations shown in the table below for both the devices:
| Interferent | Concentration (mg/dL) tested |
| --- | --- |
| Acetaminophen | 15.0 |
| Ascorbic acid | 5.0 |
| Salicylate | 60.0 |
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| Galactose | 900.0 |
| --- | --- |
| Maltose | 900.0 |
| Xylose | 100.0 |
| Lactose | 100.0 |
| Cholesterol | 500.0 |
| Creatinine | 30.0 |
| Dopamine | 10.0 |
| Ephedrine | 10.0 |
| L-Dopa | 10.0 |
| Methyl-Dopa | 3.0 |
| Gentisic acid | 10.0 |
| Glutathione | 53.0 |
| Hydroxyurea | 4.0 |
| Ibuprofen | 50.0 |
| Tetracycline | 10.0 |
| Tolazamide | 100.0 |
| Tolbutamide | 70.0 |
| Triglycerides | 2000.0 |
| Urea | 600 |
| Uric acid | 14.0 |
| Bilirubin | 90.0 |
No obvious interference was observed with the interfering substances at therapeutic or physiological levels tested at low, medium or high glucose levels. Elevated blood triglyceride, Reducing substances such as uric acid and ascorbic acid, Acetaminophen, Dopa, Methyl-Dopa, L-Dopa, and Tolbutamide (when occurring in normal blood or normal therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately high results.
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
Accuracy study was performed by healthcare professional using capillary whole blood from the fingers, palm, forearm, upper arm, thigh and calf of 100 patients. The samples (concentration range tested from 52.9 to 388 mg/dL) were tested in singlicate using two meters and one lot of test strips (n = 2 per sample). In addition, the sponsor tested ten altered venous samples to include five samples with glucose concentration between 40.0 to 48.9 mg/dL, and another five samples with glucose concentration between 437 to 449 mg/dL. Venous blood samples from each participant were collected in parallel to measure the plasma glucose concentration by YSI. Hematocrit of each sample was determined. All capillary blood sample results were
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compared to YSI. The studies met ISO 15197:2003 accuracy criteria, e.g. $95\%$ of glucose results $< 75 \mathrm{mg} / \mathrm{dL}$ were within $\pm 15 \mathrm{mg} / \mathrm{dL}$ , and for samples $\geq 75 \mathrm{mg} / \mathrm{dL}$ , $95\%$ of results were within $\pm 20\%$ of the reference method. Results are summarized below:
Regression Analysis Professional Teseing on BGMS vs YSI - Finger testing with real patient samples and ten manipulated samples $(N = 220)$
| | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| Finger | 1.004 | 1.1953 | 0.979 |
Healthcare Professional testing vs YSI $< 75\mathrm{mg / dL}$ - Finger testing with real patient samples and ten manipulated samples $(N = 110)$
| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 13/16 (81%) | 16/16 (100%) | 16/16 (100%) |
Healthcare Professional testing vs YSI $< 75\mathrm{mg / dL}$ - Finger testing with real patient samples and ten manipulated samples $(N = 110)$
| Within ± 5% | Within ± 10% | Within ± %15 | Within ± 20% |
| --- | --- | --- | --- |
| 42/94 (45%) | 75/94 (80%) | 94/94 (100%) | 94/94 (100%) |
Regression Analysis Professional Testing on BGMS vs YSI $(N = 200)$
| | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| Finger | 1.0003 | 1.8319 | 0.9782 |
| Palm | 1.0236 | -0.8994 | 0.9661 |
| Forearm | 1.0103 | 0.1763 | 0.9701 |
| Upper arm | 0.9967 | 2.7246 | 0.954 |
| Calf | 1.0201 | -2.286 | 0.9649 |
| Thigh | 1.0609 | 8.8967 | 0.9717 |
Healthcare Professional testing vs YSI $< 75\mathrm{mg / dL}$ $(N = 100)$
| | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- |
| Finger | 10/11 (91%) | 11/11 (100%) | 11/11 (100%) |
| Palm | 6/11 (55%) | 11/11 (100%) | 11/11 (100%) |
| Forearm | 5/11 (45%) | 9/11 (82%) | 11/11 (100%) |
| Upper arm | 5/11 (45%) | 8/11 (73%) | 11/11 (100%) |
| Calf | 4/11 (36%) | 11/11 (100%) | 11/11 (100%) |
| Thigh | 6/11 (55%) | 10/11 (91%) | 11/11 (100%) |
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Healthcare Professional testing vs YSI ≥ 75 mg/dL
| | Within ± 5% | Within ± 10% | Within ± %15 | Within ± 20% |
| --- | --- | --- | --- | --- |
| Finger | 38/89 (43%) | 70/89 (79%) | 89/89 (100%) | 89/89 (100%) |
| Palm | 36/89 (40%) | 62/89 (70%) | 79/89 (89%) | 87/89 (98%) |
| Forearm | 33/89 (37%) | 61/89 (69%) | 82/89 (92%) | 87/89 (98%) |
| Upper arm | 30/89 (34%) | 56/89 (63%) | 74/89 (83%) | 86/89 (97%) |
| Calf | 28/89 (31%) | 62/89 (70%) | 79/89 (89%) | 89/89 (100%) |
| Thigh | 33/89 (37%) | 60/89 (69%) | 74/89 (83%) | 86/89 (97%) |
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Lay User Performance Study:
Lay user studies for fingerstick, palm, forearm, upper arm, calf and thigh were performed by 150 lay users and healthcare professional using fresh capillary blood samples. Labeling was provided only in English and users followed it to perform the testing. The lay user first performed the testing followed by the healthcare professional of the finger, palm, forearm, upper arm, calf and thigh. Then, immediately after the above tests were completed (within 5 minutes), venous whole blood samples were collected in EDTA tubes, plasma was separated, and tested on YSI. The samples were tested using two meters and one lot of test strips (out of 3 lots in use alternatively). All results were compared to the YSI. The studies met ISO 15197:2003 accuracy criteria, e.g. 95% of glucose results < 75 mg/dL were within ± 15 mg/dL, and for samples ≥ 75 mg/dL, 95% of results were within ± 20% of the reference method. Results are summarized below:
Regression Analysis Lay User testing on BGMS vs YSI (N=150)
| | Slope | Intercept | R² |
| --- | --- | --- | --- |
| Finger | 1.0136 | -3.7813 | 0.9705 |
| Palm | 1.0211 | -4.4124 | 0.9689 |
| Forearm | 1.0157 | -4.9605 | 0.9662 |
| Upper arm | 0.9778 | 2.0352 | 0.9567 |
| Calf | 0.9776 | 2.0215 | 0.9575 |
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| Thigh | 1.0039 | -1.3189 | 0.9561 |
| --- | --- | --- | --- |
Lay User testing vs YSI $< 75\mathrm{mg / dL}$
| | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- |
| Finger | 12/21 (57%) | 20/21 (95%) | 21/21 (100%) |
| Palm | 12/21 (57%) | 19/21 (90%) | 21/21 (100%) |
| Forearm | 12/21 (57%) | 19/21 (90%) | 21/21 (100%) |
| Upper arm | 9/21 (43%) | 18/21 (86%) | 21/21 (100%) |
| Calf | 8/21 (38%) | 20/21 (95%) | 21/21 (100%) |
| Thigh | 8/21 (38%) | 20/21 (95%) | 21/21 (100%) |
Lay User testing vs YSI $\geq 75\mathrm{mg / dL}$
| | Within ± 5% | Within ± 10% | Within ± %15 | Within ± 20% |
| --- | --- | --- | --- | --- |
| Finger | 54/129 (42%) | 88/129 (68%) | 123/129 (95%) | 128/129 (99%) |
| Palm | 56/129 (43%) | 88/129 (68%) | 113/129 (88%) | 125/129 (97%) |
| Forearm | 49/129 (38%) | 88/129 (68%) | 115/129 (89%) | 128/129 (99%) |
| Upper arm | 39/129 (30%) | 82/129 (64%) | 106/129 (82%) | 128/129 (99%) |
| Calf | 44/129 (34%) | 79/129 (61%) | 113/129 (88%) | 127/129 (98%) |
| Thigh | 35/129 (27%) | 78/129 (60%) | 109/129 (84%) | 128/129 (99%) |
# 4. Clinical cut-off:
Not applicable.
# 5. Expected values/Reference range:
As per the American Diabetes Association (ADA) recommendation, the sponsor has included the following target values for people without diabetes:
Pre-prandial plasma glucose concentration (before meal) 70 to $100\mathrm{mg / dL}$
Post-prandial plasma glucose concentration $< 140\mathrm{mg / dL}$ (1-2 hours after starting a meal)
Source: American Diabetes Association Standards of Medical Care in Diabetes (2012) Diabetes Care, 35 (Supp 1), S11-S63.
# N. Instrument Name:
Prodigy Preferred Blood Glucose meter
# O. System Descriptions:
# 1. Modes of Operation:
Each test strip is single use and requires a sample volume of $0.7\mu \mathrm{L}$
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Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
☐ Yes ☑ X or No
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
☐ Yes ☐ No ☑ X
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
☐ Yes ☑ X or No
3. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.
4. Specimen Sampling and Handling:
The glucose test is intended to be used with capillary whole blood from the finger, the palm, the forearm, the upperarm, the thigh and the calf. The whole blood sample is applied directly to the test strip by capillary action.
5. Calibration:
The Prodigy Preferred Blood Glucose meter does not require coding.
6. Quality Control:
Glucose control solutions at two concentration levels can be run with this device. The meter has to be set in control solution test mode to prevent control results from being stored in the internal memory as patient result. Recommendations on when to test the control materials are provided in the labeling. The control solution readings are not included in the average of the patient results. An acceptable range for each control level is printed on the control solutions vial label. The user is cautioned not to use the meter if the control result falls outside these ranges. Low level control solution is provided with the complete kit. The meter only kit label states that control solutions are not included, and must be purchased separately.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
1. A usability study was performed to assess the readability of the labeling by recruiting 150 lay users (aged 25-75 yrs old) who were provided with the test kit containing labeling in English for the US market. Participants varied in age, education, country of origin, and both men (n
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= 110) and women (n = 40) were included in the study. These lay users also completed a questionnaire to indicate whether the device is easy to use and the Instructions for use were written in a way that makes it easy to use. The majority of the users responded that the device is very easy to use.
2. Flesch-Kincaid readability assessment was conducted and the results showed that the labeling (User Guide, test strip package insert, quick reference guide and control solution package insert) were written at grade levels ranging from 7.0th to 8.0th grade.
3. Customer service is available 24 hours, 7 days a week. The telephone number is 1-800-243-2636 for customer support.
4. The effect of different hematocrit levels on the accuracy of the Prodigy Blood Glucose Monitoring System was evaluated using ten meters in duplicates using two lots of test strips. Blood samples (anticoagulant lithium heparin) at six hematocrit levels from 20% to 60% (15, 20, 30, 40, 60 and 65%) were evaluated in five concentrations of glucose of approximately 42.8, 77.5, 127, 200 and 317 mg/dL (measured by YSI). Individual glucose measurements were compared to the reference method (YSI) and 40% HCT. The sponsor calculated individual % bias vs. YSI and 40% HCT. Results demonstrated that hematocrit levels between 20 to 60% do not significantly interfere with glucose measurements.
5. Minimum sample volume study was provided by testing a range of volumes between 0.5 to 1.5 μL (0.5, 0.6, 0.7, 0.8, 1.0, 1.2 and 1.5 μL) of heparinized venous blood samples (at five glucose concentration levels – 40, 77, 112, 177 and 336 mg/dL, measured by YSI) using eight meters and two lots of test strips. Individual glucose measurements were compared to the reference method (YSI), and percent bias were calculated. Results demonstrated that the Prodigy Meter and Prodigy No Code Test Strips require a minimum sample volume of 0.7 μL for obtaining accurate results.
5. Temperature and humidity operating conditions were evaluated for temperatures ranging from 50°F to 104°F (10°C to 40°C) and relative humidity between 10 to 85% R.H. using three glucose concentration levels of heparinized venous blood (49, 150 and 320 mg/dL, measured by YSI), seven meters and three lots of test strips. Individual glucose measurements were compared to the reference method (YSI), and percent bias were calculated. Results demonstrated that glucose measurements on the Preferred BGMS were not affected at temperatures ranging from 50°F to 104°F (10°C to 40°C) and relative humidity between 10 to 85% R.H.
6. The effect of altitude on the accuracy of the device was evaluated on the Prodigy Preferred Blood Glucose Monitoring System with three meters and three test strip lots. A range of altitudes (298, 2920, 4790, 6234, 8536 and 11161 feet) was tested using heparinized venous blood samples (at five glucose concentration levels – 49, 120, 152, 253 and 400 mg/dL, measured by YSI). Individual glucose measurements were compared to the reference method (YSI), and percent bias were calculated. Results demonstrated that glucose measurements on the Preferred BGMS were not affected up to an altitude of 11,161 feet (3,402 meters).
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7. The Preferred Blood Glucose Monitoring System is intended for home use by single person. Disinfection studies were performed on the Preferred meter to determine the robustness of the meter to the recommended cleaning and disinfection protocol, and its effectiveness in preventing the spread of bloodborne pathogens, particularly hepatitis B virus (HBV). Dispatch® Hospital Cleaner Disinfectant Towel with Bleach (EPA Reg. No. 56392-8) was validated, demonstrating complete inactivation of live virus for use with the Preferred meter. The sponsor demonstrated that there was no change in performance or in the external materials of the Preferred meter after 5000 cleaning and disinfection cycles to simulate an estimated 31 cleaning and disinfection cycles per week over three years of use at home by a single person,. Labeling has been reviewed for adequate instructions on the validated cleaning and disinfection procedures.
8. EMC testing was evaluated and certified by AUDIX Technology Corporation and a certificate of conformity was issued to Prodigy Diabetes Care LLC on December 25, 2012.
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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