(237 days)
Not Found
No
The description focuses on automated mechanical processes and photometer readings with calibration based on a barcode, not AI/ML algorithms.
No.
The device is a blood glucose monitoring system, which measures glucose levels to aid in monitoring the effectiveness of diabetes control, but it does not directly treat or provide therapy for diabetes.
Yes
This device quantitatively measures glucose in blood samples, and the "Intended Use" explicitly states it's an "aid to monitor the effectiveness of diabetes control," which falls under the definition of a diagnostic device, even though it's not used for initial diagnosis or screening.
No
The device description explicitly states that the system includes a meter with a photometer and a cartridge with test strips and a lancing mechanism, indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The POGO Automatic 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."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body to provide information about a person's health status (blood glucose levels for diabetes management). This is the core definition of an in vitro diagnostic device.
- Components: The system includes test cartridges and control solutions, which are typical components of IVD systems used for quantitative measurements.
N/A
Intended Use / Indications for Use
The POGO Automatic 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. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic 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 POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
POGO Control Solutions are used with the POGO Automatic Meter to indicate appropriate user technique and to indicate that the POGO Automatic Test Cartridge and POGO Automatic Meter are functioning properly.
Product codes
NBW, CGA, JJX
Device Description
The POGO Automatic Blood Glucose Monitoring System (POGO BGMS) is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The system includes multiple glucose-oxidase-based dry-reagent test strips housed in a cartridge and a photometer to read the glucose-dependent color change from the in-use strip. The meter uses calibration information from a barcode on the disposable cartridge to convert the reflectance information into a plasma-equivalent glucose value.
The POGO BGMS automates finger lancing, blood sample collection and placement onto the test strip, and calculation of the blood glucose result, and so requires significantly fewer steps than existing BGMSs to obtain a glucose result. The POGO BGMS accomplishes this via a 10-test cartridge where each foil-sealed test includes a hollow lancet, spring, and test strip. The user does not need a separate lancing device since the lancing mechanism is built into individual test cells of the cartridge. Additionally, used tests are retained within the cartridge for added user convenience. Control solutions are available to confirm correct system performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips
Indicated Patient Age Range
Adults and adolescents (13 and up).
Intended User / Care Setting
People with diabetes at home (self testing), healthcare professionals (for accuracy verification during studies).
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
A total of 287 subjects with diabetes were enrolled across US clinical sites. Subjects read product labeling, performed a POGO BGMS test, had a finger sample obtained for accuracy validation against a YSI reference instrument. Subjects were observed by health care professionals (HCPs) to assess ease of use and completed questionnaires to assess labeling understanding, self-reported ease-of-use, and comparison to their current BGMS. HCPs also performed assisted fingerstick tests on subjects meeting pre-specified criteria for accuracy verification against the YSI reference instrument.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Data:
- Repeatability with Whole Blood: Five whole blood samples (41.8 mg/dL to 306.7 mg/dL) were tested in replicates of 10 with 10 meters. %CVs ranged from 2.3% to 3.4%. Protocol acceptance criteria met.
- Intermediate Precision with Commercial Controls: Three levels of commercial controls (approx. 30, 100, and 300 mg/dL) tested in duplicate with 10 meters over 10 days. %CVs were 6.5% (2.1 SD), 3.1%, and 3.2% respectively. Protocol acceptance criteria met.
- Linearity: One whole blood sample spiked with nine glucose levels (17 mg/dL to 529 mg/dL), tested in replicates of 10. Protocol acceptance criteria met.
- Hematocrit Tolerance: Studies with four glucose levels (60, 120, 250, 400 mg/dL) and seven hematocrits (20% to 60%). Protocol acceptance criteria met.
- Altitude Tolerance: Studies at sea level, 5,000 feet, and 10,000 feet with blood at nominal glucose levels of 60, 120, and 300 mg/dL. Protocol acceptance criteria met.
- Temperature Tolerance: Testing at five temperatures (4℃ to 40℃) and nominal glucose levels of 60, 120, and 300 mg/dL. Protocol acceptance criteria met.
- Humidity Tolerance: Testing at 10%, 50%, and 90% relative humidity (RH) and nominal glucose levels of 60, 120, and 300 mg/dL. Protocol acceptance criteria met.
- Combinations of Temperature and Humidity Tolerance: Testing at 25°C and 45% RH, and at four extreme conditions (10℃ and 40℃ crossed with 10% and 90% RH). Three nominal glucose levels (60, 120, and 300 mg/dL) were used. Protocol acceptance criteria met.
- Sample Volume Tolerance: Studies across a range of whole blood volumes (from less than 250 nL to 1000 nL) at nominal glucose levels of 60, 120, and 300 mg/dL. At less than 250 nL, either no result or accurate result was provided. Protocol acceptance criteria met.
- Interfering Substances: Challenged at two glucose concentrations (approx. 80 mg/dL and 320 mg/dL) with therapeutic and toxic levels of multiple potentially interfering substances. No interference beyond acceptance criteria. Protocol acceptance criteria met.
- Test Range Limits: Challenged with blood spiked to 10, 550, and 1100 mg/dL. Meter displayed "LO" for 500 mg/dL. No numeric results displayed outside range. Protocol acceptance criteria met.
- Open Test Tolerance: Tested to verify length of time a test can be open prior to use. Nominal blood glucose levels of 80 and 320 mg/dL. Protocol acceptance criteria met for 6.5 minute time point.
- Open Cartridge Tolerance: Supported 45 days of open cartridge stability in terms of time, temperature (4°C-30°C) and humidity (10-90%). Tested using venous whole blood spiked to nominal glucose levels of 80 mg/dL and 320 mg/dL. Protocol acceptance criteria met.
Clinical Data:
- Accuracy (User self-testing): 100% of POGO BGMS self-test results were within ±15 mg/dL of YSI at 80% felt it was more convenient. 51% agreed they would better adhere to testing schedule. >81% agreed/strongly agreed they would recommend to a friend.
- Adverse Events: No adverse events reported during studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy data:
- User Self-Testing:
*
§ 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
April 25, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INTUITY MEDICAL, INC c/o CINDY DOMECUS DOMECUS CONSULTING SERVICES, LLC 1171 BARROILHET AVENUE HILLSBOROUGH CA 94010
Re: K152493
Trade/Device Name: Pogo Automatic Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JJX Dated: August 31, 2015 Received: September 2, 2015
Dear Ms. Domecus:
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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/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 Industry and Consumer Education 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.
Sincerely yours.
Katherine Serrano -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
2
Indications for Use
510(k) Number (if known) K152493
Device Name
POGO Automatic Blood Glucose Monitoring System
Indications for Use (Describe)
The POGO Automatic 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. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic 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 POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
POGO Control Solutions are used with the POGO Automatic Meter to indicate appropriate user technique and to indicate that the POGO Automatic Test Cartridge and POGO Automatic Meter are functioning properly.
| 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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Intuity Medical. The logo features a circular icon with a stylized "i" inside, followed by the word "intuity" in a bold, sans-serif font. Below "intuity" is the word "MEDICAL" in a smaller font. To the right of "intuity" is the tagline "Simplifying Diabetes" in a lighter font.
510(k) Summary
1 510(k) Owner
| Owner: | Intuity Medical, Inc. |
|---|---|
| Address: | 526 Almanor Avenue |
| Sunnyvale, CA 94085 | |
| Phone: | (408) 530-1700 x275 |
| Fax: | (408) 530-1717 |
| Contact: | Robb Hesley |
2 Submission Correspondent:
Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC (650) 343-4813
3 Date Summary Prepared: April 20, 2016
4 Device name - trade name and common name, and classification
| Trade Name | POGO® Automatic™ Blood Glucose
Monitoring System | POGO® Control Solution |
|----------------|-----------------------------------------------------|-----------------------------------------------------|
| Common Name | Glucose Test System | Quality control material (assayed
and unassayed) |
| Classification | Class II | Class I |
| Regulations | 21 CFR 862.1345 | 21 CFR 862.1660 |
| Product Codes | NBW, CGA | JJX |
| Panel | Clinical Chemistry | Clinical Chemistry |
5 Identification of the legally marketed predicate device
The POGO® Automatic™ Blood Glucose Monitoring System (POGO BGMS) is substantially equivalent to the Accu-Chek Compact Plus Blood Glucose Monitoring System (Roche Diagnostics, Inc., Indianapolis, IN), cleared under K081389 on July 15, 2008.
The POGO Control Solutions are substantially equivalent to Glucose Meter-Check® Solution Roche Accu-Chek (Bionostics, Inc., Devens, MA), cleared under K123851 on February 14, 2013.
4
6 Device Description
The POGO Automatic Blood Glucose Monitoring System (POGO BGMS) is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The system includes multiple glucose-oxidase-based dry-reagent test strips housed in a cartridge and a photometer to read the glucose-dependent color change from the in-use strip. The meter uses calibration information from a barcode on the disposable cartridge to convert the reflectance information into a plasma-equivalent glucose value.
The POGO BGMS automates finger lancing, blood sample collection and placement onto the test strip, and calculation of the blood glucose result, and so requires significantly fewer steps than existing BGMSs to obtain a glucose result. The POGO BGMS accomplishes this via a 10-test cartridge where each foil-sealed test includes a hollow lancet, spring, and test strip. The user does not need a separate lancing device since the lancing mechanism is built into individual test cells of the cartridge. Additionally, used tests are retained within the cartridge for added user convenience. Control solutions are available to confirm correct system performance.
7 Indications for Use
The POGO Automatic 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.
The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic 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 POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
POGO Control Solutions are used with the POGO Automatic Meter to indicate appropriate user technique and to indicate that the POGO Automatic Test Cartridge and POGO Automatic Meter are functioning properly.
5
8 Technological Characteristics Comparison
POGO BGMS
| CHARACTERISTIC | POGO BGMS | Accu-Chek |
|---|---|---|
| Compact Plus | ||
| K081389 | ||
| Intended Use | Quantitative measurement of blood | |
| glucose | Same | |
| Indications For Use | The POGO Automatic 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. | ||
| The POGO Automatic Blood Glucose | ||
| Monitoring System is intended to be | ||
| used by a single person and should not | ||
| be shared. | ||
| The POGO Automatic 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 | ||
| POGO Automatic Blood Glucose | ||
| Monitoring System should not be used | ||
| for the diagnosis of or screening of | ||
| diabetes or for neonatal use. The POGO | ||
| Automatic Blood Glucose Monitoring | ||
| System is indicated for use in adults and | ||
| adolescents (13 and up). | ||
| POGO Automatic Test Cartridges are for | ||
| use with the POGO Blood Glucose | ||
| Meter to quantitatively measure glucose | ||
| (sugar) in fresh capillary whole blood | ||
| samples drawn from the fingertips. | ||
| POGO Control Solutions are used with | ||
| the POGO Blood Glucose Meter to | ||
| indicate appropriate user technique and | ||
| to indicate that the test cartridge and | ||
| meter are functioning properly. | The Accu-Chek Compact Test | |
| Drums are used with the Accu- | ||
| Chek Compact or Compact Plus | ||
| Meter. The Accu-Chek Compact | ||
| and Compact Plus System is | ||
| designed to quantitatively | ||
| measure the concentration of | ||
| glucose in capillary and venous | ||
| whole blood. The device is | ||
| indicated for professional use and | ||
| over-the-counter sale. The Accu- | ||
| Chek Compact and Compact Plus | ||
| System are indicated for lay | ||
| person use with capillary whole | ||
| blood samples drawn from the | ||
| fingertips, forearm, upper arm, | ||
| thigh, calf, and palm. | ||
| Rx/OTC | OTC | Same |
| Classification | ||
| Regulation | 862.1345 | Same |
| Product Codes | NBW, CGA | NBW, LFR |
| Product Design | Battery-powered handheld meter | Same |
| Automatic Blood | ||
| Sample Collection | YES | NO |
| Cal Coding | Automated | Same |
| CHARACTERISTIC | POGO BGMS | Accu-Chek |
| Compact Plus | ||
| K081389 | ||
| Detection Method | Photometric (LED) | Same |
| Enzyme | Glucose oxidase | Glucose dehydrogenase |
| Hematocrit Range | 20% to 60% | 25% to 65% |
| Humidity Range | 10 - 90% RH | 15% - 85% RH |
| Lancing Device | Integrated in Meter with Strip/Lancet in | |
| Cartridge | Detachable from Meter | |
| Measurement Range | 20-500 mg/dL | 10-600 mg/dL |
| Minimum Sample | ||
| Size | 0.25 µL | 0.6 µL |
| Monitor Memory | 500 results | Same |
| Operating | ||
| Temperature Range | 50 to 104° F | Same |
| Power Source | 2 AAA batteries | Same |
| Test Strip | ||
| Configuration | 10 Test Cartridge | 17 Test Strip Drum |
| Principle of | ||
| Operation | Glucose is oxidized by the enzyme | |
| glucose oxidase and electrons are | ||
| transferred to form the intermediate | ||
| hydrogen peroxide. Horseradish | ||
| peroxidase catalyzes the transfer of | ||
| electrons between hydrogen peroxide | ||
| and precursor dye molecules to form a | ||
| blue oxidation product, the concentration | ||
| of which is proportional to the | ||
| concentration of glucose in the sample. | ||
| The amount of color formed is read by a | ||
| photometer in the meter. | Glucose is oxidized by the | |
| enzyme PQQ-dependent glucose | ||
| dehydrogenase and electrons are | ||
| transferred to form a reduced | ||
| mediator intermediate. The | ||
| reduced mediator transfers | ||
| electrons to a dye molecule, | ||
| which turns blue when reduced, | ||
| the concentration of which is | ||
| proportional to the concentration | ||
| of glucose in the sample. The | ||
| amount of color formed is read by | ||
| a photometer in the meter. |
6
Comparison of Indications for Use
POGO BGMS and the listed predicate device have the same intended use; namely, the quantitative measurement of blood glucose. The proposed indications for use are narrower than those of the predicate device, since only indicated for fingerstick testing and only by a single person in the home setting. Fingerstick testing is the most often recommended site for blood glucose monitoring devices. Single person use only provides additional protection against blood borne pathogen transmission.
Comparison of Technological Characteristics
The technology used in the POGO BGMS is similar to that used in the predicate device. Similar elements include: a motor-driven multi-strip drum with a barcode containing expiration and calibration information, a means to lance the subject, a capillary channel to automate blood delivery from the fingerstick wound to the reagent section of the test strip, and an optical system to read color developed on the test strip. The test strips are
7
all dry-reagent chemistries specific for glucose in samples of whole blood delivered via capillary action.
Differences between the POGO BGMS and the predicate device include: a different enzyme in the test strip (glucose oxidase in POGO BGMS and glucose dehydrogenase in the predicate), a new, sterile, single-use and auto-disabling lancet is provided with every test in the POGO BGMS versus user-controlled lancet replacement or re-use in the predicate, smaller minimum sample volume in POGO BGMS (0.25 uL versus 0.6 uL in the predicate), a different number of strips in the cartridge (10 in POGO BGMS vs 17 in predicate), and an automatic storage of used test strips and lancets within the cartridge for POGO BGMS versus user-required disposal of at least the test strip after every test in the predicate.
| CHARACTERISTIC | POGO Control Solutions | Glucose Meter-Check Solution
Roche Accu-Chek
K123851 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To test performance of blood glucose test system | Same |
| Indications for Use | POGO Control Solutions are used with the POGO Blood Glucose Meter to indicate appropriate user technique and to indicate that the test cartridge and meter are functioning properly
POGO Control Solution should be used for patient training and educational purposes | Glucose Meter-Check Solution Roche Accu-Chek is intended to assess the performance of the following Roche Accu-Chek blood glucose monitoring systems:
Roche Accu-Chek Aviva and Accu-Chek Aviva Combo using Aviva Plus test strips
Roche Accu-Chek Active using Accu-Chek Active test strips
Roche Accu-Chek Compact Plus using Accu-Chek Compact test strips
Roche Accu-Chek Advantage using Comfort Curve test strips |
| Classification
Regulation | 862.1660 | Same |
| Product Codes | JJX | Same |
| Value Assignment | Determined by analysis of glucose in control solution on commercial lots of test strips | Determined by analysis of glucose on commercial lots of test strips qualified for proper measurement using manufacturer recommended control solution |
| Target Range | Level 1 midpoint target is 150 mg/dL
Level 2 midpoint target is 75 mg/dL | Midpoint values assignment of 108 to 147 mg/dL depending on meter type |
| Auto Dose Test Strip | Yes | No |
| Auto QC Detection | Yes | Yes, for some meter types |
POGO Control Solutions
8
| CHARACTERISTIC | POGO Control Solutions | Glucose Meter-Check Solution
Roche Accu-Chek
K123851 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Auto Pass/Fail
Detection | Yes | No |
| Matrix | Water, buffers, salts, viscosity modifier,
glucose, preservatives, dyes | Same |
| Container | Individual, single use 25 uL HDPE
wand inside foil pouch
Level 1 wand is blue HDPE
Level 2 wand is red HDPE | 6 mL white LDPE |
| Analyte | Glucose, purified chemical source | Same |
| Color | Red | Same |
Comparison to Predicate
POGO Control Solutions are intended to indicate whether the meter and cartridge are performing correctly. The solution is supplied in a single-use plastic wand that is foil packaged. There are two levels of control solution available and are easily distinguishable by the color of the wand-Level 1 control solution is a blue wand, and Level 2 control solution is a red wand. The solution itself is similar to the predicate device in multiple ways-it is a buffered, aqueous, viscosity-modified solution containing a known quantity of glucose. The way in which the response range is determined is similar to the predicate; the solution is tested on each cartridge lot, and an allowed range of ± 15% is placed around the mean calculated glucose response. The fact that the sample being run on the BGMS is control solution is automatically detected by the BGMS and reported to the user in both the predicate and POGO systems.
The POGO control solution differs from the predicate in the following ways:
- The control solution wand is a single-use disposable applicator containing less than 50 uL of solution and allows the user to complete a control solution test via the automated lancing and sample transport features of the POGO BGMS. The user follows the same steps as for a blood test, but presses the control solution wand on the meter test port instead of their finger.
- The POGO BGMS is designed to automatically distinguish Level 1 from Level 2 control and automatically report a "P"ass or "F"ail result on the display by evaluating whether the result of the control solution test is within 15% of the value encoded on the cartridge barcode for each level of control solution.
9
9 Brief Discussion of Nonclinical Data
A series of analytical studies were performed with the POGO BGMS to support substantial equivalence, and the summarized performance data were as follows:
Repeatability with Whole Blood:
Five whole blood samples ranging from 41.8 mg/dL to 306.7 mg/dL were tested in replicates of 10 with 10 meters. The %CVs ranged from 2.3% to 3.4%. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides repeatable results.
Intermediate Precision with Commercial Controls:
Three levels of commercial controls (approximately 30, 100, and 300 mg/dL) were tested in duplicate with 10 meters over 10 days. The %CVs were 6.5% (2.1 SD), 3.1%, and 3.2% for the three levels, respectively. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides precise results.
Linearity:
One whole blood sample was spiked with nine levels of glucose ranging from 17 ms/dL to 529 mg/dL: the samples were tested in replicates of 10. The protocol acceptance criteria were met, demonstrating that the POGO BGMS is linear throughout the claimed dynamic range.
Hematocrit Tolerance:
Studies were done with four levels of glucose (60, 120, 250, and 400 mg/dL) and seven different hematocrits ranging from 20% to 60%. The protocol acceptance criteria were met. demonstrating that the POGO BGMS is accurate throughout the claimed 20-60% hematocrit range.
Altitude Tolerance:
Studies were performed at sea level. 5.000 feet. and 10.000 feet altitude with blood at nominal glucose levels of 60, 120, and 300 mg/dL. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results at altitudes up to the claimed 10,000 feet.
Temperature Tolerance:
Temperature testing was performed at five temperatures from 4℃ to 40℃ and at nominal glucose levels of 60. 120. and 300 mg/dL. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results across both the tested 4°C to 40°C range and the claimed temperature range of 10°C to 40°C.
Humidity Tolerance:
Humidity testing was performed at 10%. 50%. and 90% relative humidity (RH) and nominal glucose levels of 60. 120. and 300 mg/dL. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results when tested across the claimed humidity range of 10% to 90% RH.
10
Combinations of Temperature and Humidity Tolerance:
Testing was performed at nominal conditions of 25°C and 45% relative humidity (RH), and at four extreme conditions of 10℃ and 40℃ crossed with 10% and 90% RH. Three nominal glucose levels of 60, 120, and 300 mg/dL were used. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results at extreme combinations of temperature and humidity.
Sample Volume Tolerance:
Studies were done to confirm the accuracy of the POGO BGMS across a range of whole blood volumes. from less than the claimed minimum amount (minimum claim
250 nL) to volumes beyond what can be achieved in normal device usage, and at nominal glucose levels of 60, 120, and 300 mg/dL. The system was accurate when tested with a sample volume between 250 and 1000 nL. At sample volumes of less than the 250 nL claimed minimum volume, the POGO BGMS provided either no result, or an accurate glucose result. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results across a wide range of sample volumes.
Interfering Substances:
The POGO BGMS was challenged at two glucose concentrations (approximately 80 mg/dL and 320 mg/dL) with both therapeutic and toxic levels of multiple potentially interfering substances, including bilirubin, cholesterol, hemoglobin, triglycerides, uric acid, multiple common medications, and alternate sugars. No interference beyond the acceptance criteria was noted. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results when the sample contains up to the tested concentrations of potentially interfering substances.
Test Range Limits:
The behavior of the POGO BGMS at the high and low limits of quantitation were challenged with blood spiked to levels of 10, 550, and 1100 mg/dL. The meter displayed "LO" for all tested glucose levels below 20 mg/dL and "HI" for all tested glucose levels above 500 mg/dL. No numeric glucose results were displayed. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides correct responses with blood samples outside of the claimed quantitation range of the system.
Open Test Tolerance:
Testing was performed to verify the length of time a test can be open prior to use and still meet system accuracy requirements. Nominal blood glucose levels of 80 and 320 mg/dL were tested. The protocol acceptance criteria were met for the 6.5 minute time point, demonstrating that the POGO BGMS provides accurate results at up to the claimed 5 minutes of open time prior to the start of a test.
Open Cartridge Tolerance:
Testing was performed to support the entire open cartridge stability claim in terms of time, temperature (4°C-30°C) and humidity (10-90%). Cartridges were tested after up
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45 days of exposure in the environmental chamber using venous whole blood spiked to nominal glucose levels of 80 mg/dL and 320 mg/dL. The protocol acceptance criteria were met, demonstrating that the POGO BGMS provides accurate results for the claimed open cartridge duration of 45 days.
10 Brief Description of Clinical Data
A total of 287 subjects with diabetes were enrolled across US clinical sites: the subjects represented a wide range of demographic factors. Subjects were asked to read the product labeling, perform a POGO BGMS test on themselves, and then allow a finger sample to be obtained for accuracy validation versus the YSI reference instrument. Subjects were observed by health care professionals (HCPs) to assess their ease of use of the POGO BGMS, and were also asked to complete questionnaires to assess their understanding of the labeling and their self-reported ease-of-use of the system, as well as provide a comparison between the POGO BGMS and their current BGMS. HCPs also performed assisted fingerstick tests on subjects meeting pre-specified criteria for accuracy verification versus the YSI reference instrument. During the studies, no adverse events were reported.
During user self-testing for system accuracy validation, a total of 100% of POGO BGMS self-test glucose results were within ±15 mg/dL of the reference YSI results at a glucose concentration of 80% of the subjects felt that the POGO BGMS was more convenient than their current BGMS. A majority, 51%, of subjects agreed that they would better adhere to their healthcare professional's recommended testing schedule using the POGO BGMS and > 81% of subjects either agreed or strongly agreed that they would recommend POGO BGMS to a friend.
11 Conclusions from Nonclinical and Clinical Testing
Results from the nonclinical and clinical testing using the POGO Blood Glucose Monitoring System demonstrate that the POGO BGMS is substantially equivalent to the predicate devices. The POGO BGMS is safe and effective for its intended use and performs as well as or better than the predicate devices.