LIPIDPRO SYSTEM
Device Facts
| Record ID | K090405 |
|---|---|
| Device Name | LIPIDPRO SYSTEM |
| Applicant | Infopia Co, Ltd. |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Dec 1, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
LipidPro™ system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro™ system which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are < 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported. Glucose measurement is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly. LipidPro™ Total Cholesterol control solution, HDL-cholesterol control solution, Triglyceride control solution, and Glucose control solution are used to test the precision of the LipidPro™ system and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only.) LipidPro™ control solutions are intended for in home and health care professionals use.
Device Story
LipidPro system measures glucose and lipid profile (TC, HDL-C, TG) in capillary whole blood; calculates LDL-C. Glucose testing uses electrochemical amperometry (glucose oxidase/hexaammineruthenium chloride); lipid testing uses colorimetric reflectance photometry (enzyme-based color change). Meter features dual ports for glucose and lipid strips; uses capillary rods for lipid samples. Operated by patients (home) or healthcare professionals (clinic). Output displayed on meter; aids in management of diabetes and lipid disorders. Provides quantitative concentration values; LDL-C reported only if TG ≤ 350 mg/dL. Benefits include point-of-care monitoring of metabolic parameters.
Clinical Evidence
Clinical performance evaluation conducted to validate accuracy of TC, HDL-C, LDL-C, TG, and glucose measurements. Non-clinical verification and validation testing established performance, functionality, and reliability against predicate specifications. Results demonstrated substantial equivalence.
Technological Characteristics
Meter: 109x57.2x22.9mm, 77.5g, 2xAAA batteries. Glucose: Amperometric (carbon electrode, glucose oxidase, hexaammineruthenium chloride). Lipids: Reflectance photometry (cholesterol esterase/oxidase, peroxidase, 4-AAP, DAOS/MAOS). Connectivity: RFID/color-bar auto-coding. Operating range: 18-30°C, 10-90% RH. Standalone device.
Indications for Use
Indicated for diabetic patients or health care professionals for quantitative measurement of glucose in capillary whole blood (fingertip, palm, hand, arm, forearm, calf, thigh) as an aid in diabetes management; and for patients requiring lipid monitoring (TC, HDL-C, TG) for lipid/lipoprotein metabolism disorders, atherosclerosis, or liver/renal disease. Not for neonatal use, diabetes screening/diagnosis, or critically ill/shock/hypotensive patients.
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
- Polymer Technology Systems Lipid Panel Evolution™ Blood Glucose Monitoring System (k023558)
- PTS panels multi-chemistry controls (k072369)
- PTS panels multi-chemistry control Solution (k022401)
Related Devices
- K130295 — LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. · Infopia Co, Ltd. · Jun 21, 2013
- K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System · ACON Laboratories, Inc. · Jul 11, 2017
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k090405
B. Purpose for Submission:
New device
C. Measurand:
Whole blood Glucose, Total cholesterol, HDL-cholesterol, Triglycerides, calculated LDL-cholesterol
D. Type of Test:
Quantitative, electrochemical for glucose (using glucose oxidase) and colorimetric for lipids
E. Applicant:
Infopia Co., Ltd.
F. Proprietary and Established Names:
LipidPro™ system, model ILM-0001A
LipidPro™ Total cholesterol control solution
LipidPro™ HDL-cholesterol control solution
LipidPro™ Triglyceride control solution
LipidPro™ Glucose control solution
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CGA – Glucose oxidase, glucose | Class II | 21 CFR § 862.1345 | 75-Chemistry |
| NBW – system, test, blood glucose, over the counter | Class II | 21 CFR § 862.1345 | 75-Chemistry |
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| CHH- Total Cholesterol | Class I, meet limitations of exemptions per 21 CFR 862.9(c)(4)(9) | 21 CFR § 862.1175 | 75-Chemistry |
| --- | --- | --- | --- |
| LBR- HDL-Cholesterol | Class I, meet limitations of exemptions per 21 CFR 862.9(c)(4)(9) | 21 CFR § 862.1475 | 75-Chemistry |
| JGY- Triglycerides | Class I, meet limitations of exemptions per 21 CFR 862.9(c)(4)(9) | 21 CFR § 862.1705 | 75-Chemistry |
| JJX – Quality Control material | Class I, reserved | 21 CFR § 862.1660 | 75-Chemistry |
H. Intended Use:
1. Intended use(s):
See indications for use below
2. Indication(s) for use:
LipidPro™ system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro™ system which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are ≤ 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported.
Glucose measurement is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during
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steady- state times when glucose is not changing rapidly.
**Quality control solution:**
- LipidPro™ Total cholesterol control solution
- LipidPro™ HDL-cholesterol control solution
- LipidPro™ Triglyceride control solution
- LipidPro™ Glucose control solution
- LipidPro™ Total Cholesterol control solution, HDL-cholesterol control solution, Triglyceride control solution, and Glucose control solution are used to test the precision of the LipidPro system and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only.)
3. **Special conditions for use statement(s):**
- For over-the-counter and prescription use
- Not for neonatal use, not for screening or diagnosis of diabetes mellitus.
Critically ill patients should not be tested with blood glucose meters. Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
The sponsor has the following recommendation in the labeling:
> "Use LipidPro™ system at the frequency your doctor recommends testing for total cholesterol, HDL-cholesterol, and triglyceride."
4. **Special instrument requirements:**
- LipidPro™ meter
I. **Device Description:**
The LipidPro™ test system consists of a meter, five types of test strips, and four types of control solutions. The five types of the test strips are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), a lipid profile (which combines TC, HDL-C, and TG tests) and glucose test respectively. The four types of control solutions are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose test respectively. LDL value is calculated from TC, HDL-C, and TG values using the
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numerical formula: LDL=TC-HDL-(TG/5). When TG is over 350 mg/dL, LDL is not calculated.
## LipidPro™ Lipid profile and glucose measuring system kit contents:
1. LipidPro™ Meter
2. Instructions for Use
3. Warranty Card
4. Carrying Case
5. Two AAA batteries
6. Lancing Device
7. Lancet
## Required but not provided:
- LipidPro™ Brand Test Strips (5 different types: total cholesterol, HDL-cholesterol, triglyceride, lipid profile, and glucose)
- LipidPro™ Brand Control Solutions (4 different types: total cholesterol, HDL-cholesterol, triglyceride, and glucose)
- Capillary Rods
- Control Solution Range Cards
## LipidPro™ meter:
LipidPro™ meter has a dimension of 109(H) x 57.2(D) x 22.9 (T) mm, weight 77.5g and requires two AAA batteries to operate. There are two separate test strip insertion ports. The glucose strip is at the top of the meter and the lipid strip inserting part is at the bottom of the meter. A capillary rod is used to collect the blood samples for the lipid tests while glucose strip is direct blood sample application.
## Test strips:
1. Each box of LipidPro Total cholesterol test strip contains the following contents:
- 10 total cholesterol testing strips
- 10 capillary rods
- 1 strip instruction manual
- 1 Control Solution range card
The test strip for testing total cholesterol is in red color, with one sample collection pad near the top end of the strip. The cholesterol test strip contains the following ingredients: cholesterol esterase: 5units; cholesterol oxidase: 3.3 units; peroxidase: 3.3 units; 4-AAP: 49 µg; and DAOS: 81 µg.
2. Each box of LipidPro HDL-cholesterol test strip contains the following contents:
- 10 total HDL-cholesterol testing strips
- 10 capillary rods
- 1 strip instruction manual
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1 Control Solution range card
The test strip for testing HDL-cholesterol is in **blue** color, with one sample collection pad near the top end of the strip. The cholesterol test strip contains the following ingredients: cholesterol esterase: 3 units; cholesterol oxidase: 1.5 units; peroxidase: 4.5 units; 4-AAP: 48 µg; MAOS: 65 µg; and Surfactant: 300 µg.
3. Each box of LipidPro Triglyceride test strip contains the following contents:
- 10 total triglyceride testing strips
- 10 capillary rods
- 1 strip instruction manual
- 1 Control Solution range card
The test strip for testing triglyceride is in **green** color, with one sample collection pad near the top end of the strip. The cholesterol test strip contains the following ingredients: lipase lipoprotein: 5 units; glycerol kinase: 9 units; glycerol-3-phosphate oxidase: 3 units; peroxidase: 4 units; ATP: 82 µg; 4-AAP: 40 µg; and DAOS: 68 µg.
4. Each box of LipidPro lipid profile test strip contains the following contents:
- 10 testing strips
- 30 capillary rods
- 1 strip instruction manual
- 1 Control Solution range card
The test strip for testing the lipid profile (which combines TC, HDL-C, and TG tests) is in **black** color, with three sample collections pads on the strip. See the respective lipid test strip ingredients listed above.
5. Each box of LipidPro glucose test strip contains the following contents:
- 25 testing strips
- 1 strip instruction manual
The test strip for testing glucose contains the following reagents: Glucose Oxidase (A. niger): 1 unit; mediator (hexaammineruthenium chloride): 60 µg; binder: 1.9 µg; and stabilizer: 28.6 µg.
**Control Solutions:**
1. The LipidPro Glucose control solutions come in three levels (Lo, Normal and High) and are made of an aqueous buffer consisting of D-glucose, preservative and a non-reactive ingredient.
2. The LipidPro Total cholesterol control solutions come in two levels (Level 1 and 2) and are made of an aqueous buffer consisting of cholesterol, preservative and a non-reactive ingredient.
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3. The LipidPro HDL-cholesterol control solutions come in two levels (Level 1 and 2) and are made of an aqueous buffer consisting of HDL-cholesterol, preservative and a non-reactive ingredient.
4. The LipidPro Triglyceride control solutions come in two levels (Level 1 and 2) and are made of an aqueous buffer consisting of triglyceride, preservative and a non-reactive ingredient.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Polymer Technology Systems Lipid Panel Evolution™ Blood Glucose Monitoring System
PTS panels multi-chemistry controls
2. Predicate 510(k) number(s):
k023558
k072369
k022401
3. Comparison with predicate:
| Similarities and Differences of the Lipid profile measuring system | | |
| --- | --- | --- |
| Item | LipidPro™ lipid measuring system | PTS Lipid Panel Test Strips (k023558) |
| Intended Use | LipidPro™ system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro™ system which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis, and various liver and renal diseases. This test is designed for use by healthcare professionals and individuals for personal use at home. | The Lipid Panel Test Strips are intended to measure cholesterol, HDL-cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChekbrand) analyzer. Lipid measurements are used in the diagnosis and treatment of lipoprotein metabolism and lipid disorders (such as diabetes mellitus, atherosclerosis, and various liver and renal diseases. This test is designed for use by healthcare professionals and individuals for personal use at home. |
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| Similarities and Differences of the Lipid profile measuring system | | |
| --- | --- | --- |
| Item | LipidPro™ lipid measuring system | PTS Lipid Panel Test Strips (k023558) |
| | as diabetes mellitus), atherosclerosis and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are ≤ 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported. | |
| Detection method | Spectrophotometry | Spectrophotometry |
| Enzyme | TC: Cholesterol esterase, Cholesterol oxidase, Peroxidase
HDL-C: Cholesterol esterase, Cholesterol oxidase, Peroxidase
TG: Lipase lipoprotein, Glycerol kinase, Glycerol-3-Phosphate Oxidase, Peroxidase | Same |
| Color Fixatives | TC, HDL-C, TG: 4-aminoantipyrine
Substituted aniline derivatives | TC, HDL-C: 4-aminoantipyrine
Substituted aniline derivatives
TG: 4-aminoantipyrine
N,N-disubstituted aniline |
| Coding | Auto-coding by the RFID tag | MEMO Chip |
| Sample type | Capillary whole blood | Same |
| Humidity range | 10 ~ 90% | 20 ~ 80% |
| Power supply | 2 AAA 1.5 Volt alkaline | Same |
| Battery lifetime | 1000tests | 300tests |
| Test range | TC : 100-400 mg/dL
HDL-C: 25-80 mg/dL
TG: 70-600 mg/dL | TC : 100-400 mg/dL
HDL-C: 25-85 mg/dL
TG: 50-500 mg/dL |
| Hematocrit | TC, HDL-C, TG: | TC: 30~50% |
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| Similarities and Differences of the Lipid profile measuring system | | |
| --- | --- | --- |
| Item | LipidProTM lipid measuring system | PTS Lipid Panel Test Strips (k023558) |
| range | 30~55% | HDL-C: 30~45%
TG: 15~55% |
| Test time | 1-2 minutes | 1-2 minutes |
| Sample volume | 5 μl | 15 μl |
| Temperature range | 18-30°C (64~86°F) | 18-35°C (64.4-95°F) |
| Size L x W x H (cm) | 10.9 X 6.04 X 2.29 | 13.97 X 7.62 X 2.54 |
| Weight | 77.5 g | 121.9 g |
| Similarities and Differences of the Blood Glucose System | | |
| --- | --- | --- |
| Item | LipidProTM glucose measuring system | Evolution glucose system (k072369) |
| Intended Use | LipidProTM system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). Glucose measurement is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly. | The Evolution Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood taken from fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Evolution Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady state times when glucose is not changing rapidly. |
| Detection method | Amperometry | Same |
| Enzyme | Glucose Oxidase | Same |
| Mediator | Hexaammineruthenium(III)Chloride | Same |
| Electrode | Carbon electrode | Same |
| Coding | Auto-coding by the color bar | Same |
| Sample type | Capillary whole blood | Same |
| Humidity range | 10~90% | 20~80% |
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| Similarities and Differences of the control solution | | |
| --- | --- | --- |
| Item | LipidProTM Control Solution | PTS panels multi-chemistry control Solution (k022401) |
| Intended use | LipidProTM Total Cholesterol control solution, HDL-cholesterol control solution, Triglyceride control solution, and Glucose control solution are used to test the precision of the LipidPro system and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only.) | The PTS panels multi-chemistry controls are intended for use on the BioScanner2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home. |
| Analyte | Total Cholesterol (TC), HDL-Cholesterol (HDL-C), Triglyceride, Glucose | Cholesterol, triglyceride, glucose, and ketones |
| Number of levels | TC: 2 levels (normal, abnormal) HDL-C: 2 levels (normal, abnormal) TG: 2 levels (normal, abnormal) Gluc: 3 levels (low, medium, and high) | 2 levels (level 1, level 2) |
| Container | Bottle | Same |
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| Similarities and Differences of the control solution | | |
| --- | --- | --- |
| Item | LipidProTM Control Solution | PTS panels multi-chemistry control Solution (k022401) |
| Color | Clear | Same |
| Storage temperature | 8~30°C(46~86°F) | 20~30°C(68~86°F) |
| Fill volume | 1.0mL | 1.5mL |
# K. Standard/Guidance Document Referenced (if applicable):
ISO 15197: In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 14971: Medical Devices-Application of Risk Managing Medical Devices
CEN 13640: Stability Testing of In Vitro Diagnostic Medical Devices
CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods
CLSI EP6-A: Evaluation of the Linearity of Quantitative Analytical Methods
CLSI EP7-A2: Interference Testing in Clinical Chemistry
CLSI EP9-A2: Method Comparison and Bias Estimation Using Patient Samples;
# L. Test Principle:
LipidPro system has two different test principles: one for glucose and the other for the lipid profile (total cholesterol, HDL-cholesterol, and triglyceride)
The LipidPro blood glucose test is based on measurement of electrical current caused by the reaction of glucose with the reagents on the electrode of the test strip. The blood sample is drawn into the end of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and hexaamineruthenium chloride, generating a current that is proportional to the glucose concentration in the sample. The result is shown on the meter display after 3 seconds.
The LipidPro profile test results are based on reading reflection density. When the blood is applied, the color changes in the test area through an enzyme reaction. The meter records this change in color and converts the measurement signal to the displayed result using the data previously entered via the code. The color changes are proportional to the lipid concentration in the sample. The result is shown on the meter display after 2 minutes.
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M. Performance Characteristics (if/when applicable):
1. Analytical performance:
Total cholesterol and HDL-cholesterol were certified by the Cholesterol Reference Method Laboratory Network (CRMLN) as meeting the National Cholesterol Education Program's (NCEP) performance criteria for accuracy and precision. CRMLN certifications for specific device is available at http://www.cdc.gov/labstandards/crmln.htm
a. Precision/Reproducibility:
i.) Precision evaluation for glucose measurement:
Within-run Precision was measured by using EDTA anti-coagulated whole blood at five different glucose concentrations. Each sample was tested 10 times on ten different meters (N=100). Results are summarized below:
Within-run precision for glucose:
| Level | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- |
| 1 | 45.0 | 1.4 | 3.1 |
| 2 | 84.7 | 1.8 | 2.1 |
| 3 | 130.8 | 2.8 | 2.2 |
| 4 | 206.2 | 5.4 | 2.6 |
| 5 | 341.8 | 8.2 | 2.4 |
Between-day precision was measured by reading three different control materials once a day for 10 days on ten different meters (N = 100). Results are summarized below:
Between-day precision for glucose:
| Level | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- |
| 1 | 49.7 | 1.1 | 2.3 |
| 2 | 100.5 | 1.7 | 1.7 |
| 3 | 300.3 | 2.2 | 0.7 |
ii.) Precision evaluation for total cholesterol, HDL cholesterol, and triglyceride measurements:
With-run precision was evaluated according to CLSI EP05-A guideline. Three EDTA whole blood samples were each tested ten times in 3 runs using 3 lots of strips on 5 separate meters within one day (N=450). Results are summarized below:
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Individual strips for within-run precision for cholesterol, HDL-C, and triglyceride:
| Analyte | Concentration | With-run precision | |
| --- | --- | --- | --- |
| | Mean [mg/dL] | SD [mg/dL] | CV [%] |
| Chol. | 120.0 | 1.9 | 1.6 |
| Chol. | 231.8 | 3.2 | 1.4 |
| Chol. | 349.7 | 4.0 | 1.1 |
| HDL-C | 30.9 | 0.8 | 2.5 |
| HDL-C | 51.9 | 1.1 | 2.1 |
| HDL-C | 73.0 | 1.6 | 2.2 |
| Trig. | 130.0 | 1.9 | 1.4 |
| Trig. | 357.2 | 5.0 | 1.4 |
| Trig. | 530.1 | 6.1 | 1.2 |
Lipid profile test strip for within-run precision for cholesterol, HDL-cholesterol, and triglyceride:
| Analyte | Concentration | With-run precision | |
| --- | --- | --- | --- |
| | Mean [mg/dL] | SD [mg/dL] | CV [%] |
| Chol. | 118.9 | 2.1 | 1.8 |
| Chol. | 236.0 | 3.4 | 1.4 |
| Chol. | 348.0 | 5.0 | 1.4 |
| HDL-C | 31.5 | 0.7 | 2.3 |
| HDL-C | 50.2 | 1.1 | 2.2 |
| HDL-C | 71.2 | 1.5 | 2.1 |
| Trig. | 128.5 | 2.2 | 1.7 |
| Trig. | 357.6 | 4.3 | 1.2 |
| Trig. | 529.0 | 6.0 | 1.1 |
Between-day precision was measured by reading two different control materials twice a day for 20 days on two separate meters $(\mathrm{N} = 80)$ . Results are summarized below:
Between-day precision for cholesterol, HDL-C, and triglyceride
| Analyte | Concentration | Total precision | |
| --- | --- | --- | --- |
| | Mean [ng/dL] | SD [ng/dL] | CV [%] |
| Chol. | 150.3 | 2.2 | 1.5 |
| Chol. | 250.6 | 3.6 | 1.4 |
| HDL-C | 59.9 | 1.3 | 2.1 |
| HDL-C | 29.9 | 0.8 | 2.7 |
| Trig. | 120.5 | 2.9 | 2.4 |
| Trig. | 250.5 | 2.8 | 1.1 |
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b. Linearity/assay reportable range:
Linearity was evaluated according to the CLSI EP06-A guideline. Linearity was performed using the LipidPro meter and the LipidPro glucose test strips, total cholesterol test strips, HDL-cholesterol test strips, and triglyceride test strips.
i.) EDTA venous whole blood was spiked or glycolyzed to produce two levels of glucose concentrations (low and high level). These two glucose concentrations were mixed in proportion to create 12 glucose concentrations with equally spaced concentrations. A total of 14 glucose concentrations were prepared with glucose concentrations ranged from 20 to 600 mg/dL. Each concentration was tested five times by the LipidPro meter and in duplicate by the YSI 2300 analyzer. Regression analysis showed a linear relationship between the LipidPro method and the YSI method: Y = 0.9983X + 0.967, R² = 0.9999
ii.) EDTA venous whole blood samples were used to prepare two levels of concentrations (low and high level) of cholesterol, HDL-cholesterol, and triglyceride. These two levels were then used to prepare four levels of intermediate concentrations. Each concentration was tested five times by the LipidPro meter and in duplicate by another laboratory method. Regression analysis showed a linear relationship between the LipidPro meter and the laboratory method. Results are summarized below:
For Total cholesterol: Y = 0.996X + 1.7212, R² = 0.9998, samples ranged from 100-400 mg/dL
For HDL-cholesterol: Y = 0.978X + 1.779, R² = 0.9946, samples ranged from 25-80 mg/dL
For Triglyceride: Y = 1.0002X + 0.7005, R² = 0.9999, samples ranged from 70-600 mg/dL
The results of the study support the sponsor’s claimed that the glucose test is linear from 20-600 mg/dL, total cholesterol test is linear from 100-400 mg/dL, HDL-cholesterol test is linear from 25-80 mg/dL, and triglyceride test is linear from 70-600 mg/dL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
The LipidPro glucose measuring system is traceable to NIST SRM 917b reference material. Method comparison information demonstrated accuracy to YSI 2300 analyzer.
Infopia Co. has documented traceability to the NCEP’s recommended accuracy base for Total Cholesterol and HDL-cholesterol by performing a direct comparison with a
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Cholesterol Reference Method Laboratory Network laboratory using fresh human specimens which cover the NCEP medical decision points.
Triglyceride does not have a reference material; it is traceable to a commercially available laboratory method through an internal procedure.
There is no calibration required to perform the LipidPro lipid profile and glucose tests; however, a lot specific code is provided with each test strip. Calibrations were done in-house and parameters were coded into the test strip. The user must check and make sure that the code number printed on the test strip vial matches the code number in the LipidPro meter before testing.
Value assignment:
The value assignment of the LipidPro control solutions were determined by an in-house procedure. The range of the control solutions was determined by assaying multiple runs of the control solutions on ten LipidPro meters. For total cholesterol control solution level 1 and 2, ranges were set at mean ± 20 mg/dL; for HDL-cholesterol control solution level 1 and 2, ranges were set at mean ± 5 mg/dL; for triglyceride control solution level 1 and 2, ranges were set at mean ± 20 mg/dL; for glucose control solution level 1, 2 and 3, ranges were set at the following:
| Glucose control solution level | Target concentration | Acceptable range |
| --- | --- | --- |
| Level 1 (low) | 50 mg/dL | Mean ± 15 mg/dL |
| Level 2 (medium) | 100 mg/dL | Mean ± 20% |
| Level 3 (high) | 300 mg/dL | Mean ± 15% |
Real time stability was performed to assess the shelf-life and open-vial stability of the control solutions and test strips for all the analytes measured (cholesterol, HDL-cholesterol, triglyceride and glucose). Stability studies protocol and acceptance criteria were provided and found to be adequate. The sponsor claimed that the unopened test strips have a 12 month shelf-life and are stable for 3 months after first use when stored at 2-8°C. Unopened control solutions have a 12 month shelf life and are stable for 3 months after first use when stored at 8-30°C.
d. Detection limit:
See linearity/reportable range study above.
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# e. Analytical specificity:
# i.) Endogenous and exogenous interferent effects:
An interference study was conducted to determine the effect of common interference substances based on the CLSI EP07-A guideline. Common interferences were evaluated by spiking venous blood with different analyte concentrations. Each of these concentrations was then spiked with the interfering compound at different concentrations to make the interference samples. Three levels of glucose concentrations (40, 160, and $320\mathrm{mg / dL}$ ) and one level (around medical decisions point) of total cholesterol, HDL, and triglycerides were tested. The $\%$ bias was calculated based on the differences between the spiked sample and the control sample. The sponsor defined no significant interference (NI) as bias $\leq \pm 10\mathrm{mg / dL}$ for glucose values $< 75\mathrm{mg / dL}$ or $\leq \pm 10\%$ for glucose values $\geq 75\mathrm{mg / dL}$ for glucose test; bias $\leq 15\%$ for total cholesterol, HDL-cholesterol, and triglyceride. If there is interference detected, the substance will be listed as an interference (I) substance in the table below and in the package insert. Based on the data, the sponsor claims no significant interference for the substances and concentrations listed in the table below:
For glucose test:
| Compound | Concentration | I/NI | Compound | Concentration | I/NI |
| --- | --- | --- | --- | --- | --- |
| Acetaminophen | ≤ 20 mg/dL | NI | Levodopa | ≤ 4 mg/dL | NI |
| Ascorbic acid | ≤ 3 mg/dL | NI | Maltose | ≤ 300 mg/dL | NI |
| Bilirubin | ≤ 40 mg/dL | NI | Methyldopa | ≤ 2.5 mg/dL | NI |
| Cholesterol | ≤ 500 mg/dL | NI | Tetracycline | ≤ 0.4 mg/dL | NI |
| Creatinine | ≤ 30 mg/dL | NI | Tolazamide | ≤ 5 mg/dL | NI |
| Dopamine | ≤ 13 mg/dL | NI | Tolbutamide | ≤ 100 mg/dL | NI |
| EDTA | ≤ 640 mg/dL | NI | Triglycerides | ≤ 3000mg/dL | NI |
| Galactose | ≤ 50 mg/dL | NI | Salicylic Acid | ≤ 50 mg/dL | NI |
| Gentisic acid | ≤ 50 mg/dL | NI | Urea | ≤ 500 mg/dL | NI |
| Glutathione | ≤ 1 mg/dL | NI | Uric Acid | ≤ 20 mg/dL | NI |
| Heparin | ≤ 100 mg/dL | NI | Xylose | ≤ 10 mg/dL | NI |
| Ibuprofen | ≤ 40 mg/dL | NI | Hemoglobin | ≤ 500 mg/dL | NI |
For Total-cholesterol test and HDL-cholesterol: Dopamine and Gentisic acid are listed as interference substances in the labeling.
| Compound | Concentration | I/NI |
| --- | --- | --- |
| Acetaminophen | ≤ 20 mg/dL | NI |
| Bilirubin | ≤ 20 mg/dL | NI |
| Glutathione | ≤ 1 mg/dL | NI |
| Heparin | ≤ 100 mg/dL | NI |
{15}
| Dopamine | ≤ 13 mg/dL | I |
| --- | --- | --- |
| EDTA | ≤ 640 mg/dL | NI |
| Gentistic acid | ≤ 10 mg/dL | I |
| Heparin | ≤ 100 mg/dL | NI |
| Hemoglobin | ≤ 500 mg/dL | NI |
| Ibuprofen | ≤ 40 mg/dL | NI |
| L-Ascorbic acid | ≤ 3 mg/dL | NI |
| Triglyceride | ≤ 3000 mg/dL | NI |
| Urea | ≤ 500 mg/dL | NI |
| Uric acid | ≤ 20 mg/dL | NI |
For the triglyceride test: Dopamine, Methyldopa and L-Ascorbic acid are listed as interference substances in the labeling.
| Compound | Concentration | I/NI |
| --- | --- | --- |
| Acetaminophen | ≤ 20 mg/dL | NI |
| Bilirubin | ≤ 20 mg/dL | NI |
| Dopamine | ≤ 13 mg/dL | I |
| Cholesterol | ≤ 400 mg/dL | NI |
| Salicylic acid | ≤ 50 mg/dL | NI |
| Methyldopa | ≤ 2.5 mg/dL | I |
| Ibuprofen | ≤ 40 mg/dL | NI |
| L-Ascorbic acid | ≤ 3 mg/dL | I |
| Uric acid | ≤ 20 mg/dL | NI |
| Hemoglobin | ≤ 500 mg/dL | NI |
# ii.) Hematocrit effect:
The sponsor evaluated the effect of hematocrit on EDTA whole blood samples spiked with five hematocrit levels (20, 30, 40, 50, and $60\%$ ) at eight glucose concentrations between $45 - 542 \mathrm{mg} / \mathrm{dL}$ . Each sample was tested 15 times on the LipidPro meter. These values were compared to values from an YSI-2300 analyzer of plasma glucose values at the hematocrit of $40\%$ (reference method). The sponsor defined no significant interference as bias of $\leq \pm 15 \mathrm{mg} / \mathrm{dL}$ for glucose values $< 75 \mathrm{mg} / \mathrm{dL}$ and $\leq \pm 15\%$ for glucose values $\geq 75 \mathrm{mg} / \mathrm{dL}$ .
The sponsor concluded that hematocrit between $30 - 55\%$ range did not show any significant hematocrit effect on the glucose results.
Another hematocrit study was performed using EDTA whole blood samples spiked with six hematocrit levels (30, 35, 40, 45, 50, and $55\%$ ) at the following analytes concentrations: Four levels of cholesterol $(132 - 283\mathrm{mg / dL})$ , five levels of HDL-
{16}
cholesterol (25-65 mg/dL), and five levels of triglyceride (74-355 mg/dL). Each sample was tested 15 times on the LipidPro meter. These values were compared to values from the laboratory method of analytes values at the hematocrit of 40% (reference method).
The sponsor concluded that hematocrit between 30-55% range did not show any significant hematocrit effect (<5%) on the total-cholesterol, HDL, and triglyceride results.
The sponsor states in their labeling that hematocrit levels less than 30% may cause falsely high reading and hematocrit levels greater than 55% may cause falsely low reading for all analytes.
iii.) Temperature and humidity studies were performed and showed that the device can be used from 18 to 30°C (64-86°F) and from 10% to 90% relative humidity for all analytes measured. An altitude study was performed and demonstrated that meter performance for glucose was not significantly affected by altitudes ≤10,000 feet.
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
i.) For LipidPro glucose test:
One forty-seven layusers performed a fingerstick test using the LipidPro glucose measuring system (LipidPro meter and LipidPro glucose test strips). A healthcare professional then performed the test on the LipidPro glucose measuring system and the Evolution Blood Glucose Monitoring System (predicate device). A venous sample was obtained and plasma samples from these patients were performed on the Hitachi 747 analyzer (reference method). The range of glucose values for the fingerstick samples was 58-488 mg/dL. In order to obtain sufficient samples in the lowest and highest concentration intervals, 13 glucose concentrations were adjusted by collecting blood in a heparin tube. Eight samples less than 50 mg/dL (33-48 mg/dL) were hydrolyzed and five samples greater than 400 mg/dL (511-563 mg/dL) were spiked with glucose. The linear regressions were as follows:
Between the lay user's finger-stick and the venous samples:
Patient's results on LipidPro (Y) vs Hitachi 747 (X):
$$
\mathrm{Y} = 0.9989\mathrm{X} + 3.3360,\ \mathrm{r}^2 = 0.9867,\ \mathrm{N} = 160
$$
{17}
Between the professional-collected finger-stick and the venous samples:
Healthcare professional's results on LipidPro (Y) vs Hitachi (X):
$$
\mathrm {Y} = 1. 0 0 8 5 \mathrm {X} + 0. 2 9 2 4, \mathrm {r} ^ {2} = 0. 9 9 3 9, \mathrm {N} = 1 6 0
$$
Based on the ISO Standard 15197 document, how well the LipidPro glucose measuring system when lay users tested themselves using a fingerstick sample as compared with the laboratory method is shown in the tables below:
System accuracy results for glucose concentration $< 75\mathrm{mg / dL}$
| Within ± 5mg/dL | Within ± 10mg/dL | Within ± 15mg/dL |
| --- | --- | --- |
| 24/27(93%) | 27/27(100%) | 27/27(100%) |
System accuracy results for glucose concentration $\geq 75\mathrm{mg / dL}$
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| --- | --- | --- | --- |
| 84/133(63%) | 119/133(89%) | 129/133(97%) | 133/133(100%) |
Based on the ISO Standard 15197 document, how well the LipidPro glucose measuring system when professionals tested the device using a fingerstick sample as compared with the laboratory method is shown in the tables below:
System accuracy results for glucose concentration $< 75\mathrm{mg / dL}$
| Within ± 5mg/dL | Within ± 10mg/dL | Within ± 15mg/dL |
| --- | --- | --- |
| 27/27(100%) | 27/27(100%) | 27/27(100%) |
System accuracy results for glucose concentration $\geq 75\mathrm{mg / dL}$
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| --- | --- | --- | --- |
| 100/133(75%) | 130/133(98%) | 133/133(100%) | 133/133(100%) |
Note: When meter results are compared to the laboratory results, results below 75 mg/dL are compared in mg/dL.
ii.) For LipidPro total cholesterol, HDL-cholesterol, and triglyceride tests:
Four hundred patients performed a fingerstick test using the LipidPro Total Cholesterol Testing System. A healthcare professional then performed the test on the LipidPro Total Cholesterol Testing System and the Cardiocheck System (predicate device). A venous sample was obtained and plasma samples from these patients were performed on the Architect c16000 analyzer (reference method). The same test protocol was used for the HDL-Cholesterol and Triglyceride testing
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systems. The linear regressions were as follows:
The range of total cholesterol values for these samples was 100-400 mg/dL.
Between the lay user's finger-stick and the venous samples:
Patient's results on LipidPro (Y) vs Architect c16000 (X):
$$
Y = 1.0013X + 2.2025, r^2 = 0.9933, N = 400
$$
Between the professional-collected finger-stick and the venous samples:
Healthcare professional's results on LipidPro (Y) vs Architect c16000 (X):
$$
Y = 1.0037X + 0.800, r^2 = 0.9952, N = 400
$$
The range of HDL-cholesterol values for these samples was 25-80 mg/dL.
Between the lay user's finger-stick and the venous samples:
Patient's results on LipidPro (Y) vs Architect c16000 (X):
$$
Y = 0.9935X + 1.2036, r^2 = 0.9935, N = 400
$$
Between the professional-collected finger-stick and the venous samples:
Healthcare professional's results on LipidPro (Y) vs Architect c16000 (X):
$$
Y = 0.9902X + 1.2730, r^2 = 0.9945, N = 400
$$
The range of Triglyceride values for these samples was 70-518 mg/dL.
Between the lay user's finger-stick and the venous samples:
Patient's results on LipidPro (Y) vs Architect c16000 (X):
$$
Y = 1.0169X - 0.2810, r^2 = 0.9983, N = 400
$$
Between the professional-collected finger-stick and the venous samples:
Healthcare professional's results on LipidPro (Y) vs Architect c16000 (X):
$$
Y = 1.0083X + 0.4904, r^2 = 0.9989, N = 400
$$
In addition, 259 patients performed a fingerstick test using the LipidPro lipid profile test strips on the LipidPro meter. A healthcare professional then performed the
19
{19}
same test on the LipidPro meter and the Cardiocheck System (predicate device). A venous sample was obtained and plasma samples from these patients were performed on the Abbott Architect c16000 analyzer (comparative method). The linear regressions of the lipid results were as follows:
Between the lay user's finger-stick and the venous samples on the Architect c16000:
| Analyte | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| Total cholesterol | 0.9799 | 3.5528 | 0.9862 |
| HDL-cholesterol | 0.9717 | 1.3066 | 0.9810 |
| Triglyceride | 0.9991 | 0.1868 | 0.9973 |
Between the professional-collected finger-stick and the venous samples on the Architect c16000:
| Analyte | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| Total cholesterol | 0.9844 | 2.4281 | 0.9789 |
| HDL-cholesterol | 0.9727 | 1.2221 | 0.9831 |
| Triglyceride | 1.0005 | -0.3380 | 0.9949 |
LipidPro results classification as compared with NCEP criteria
Based on the method comparison against the comparative method (Architect c16000), the majority of the individual results of the four hundred lay users, were classified correctly using NCEP criteria as shown in the chart below.
| Results Classification as Compared with NCEP Criteria | | | |
| --- | --- | --- | --- |
| | Cholesterol | HDL-Cholesterol | Triglycerides |
| Results Correctly Classified | 94% | 92% | 93% |
| Misclassified high risk (indicates the percentage of the time that your results could actually be lower than the reading you obtain) | 4% (16/400) | 6% (24/400) | 5% (20/400) |
| Misclassified lower risk (indicates the percentage of the time that your results could actually be higher than the reading you obtain) | 2% (8/400) | 2% (8/400) | 2% (8/400) |
Based on the method comparison against the comparative method for the four hundred patients when tested by healthcare professionals, the majority of the individual results were classified correctly using NCEP criteria as shown in the chart below.
{20}
| Results Classification as Compared with NCEP Criteria | | | |
| --- | --- | --- | --- |
| | Cholesterol | HDL-Cholesterol | Triglycerides |
| Results Correctly Classified | 95% | 92% | 94% |
| Misclassified high risk (indicates the percentage of the time that your results could actually be lower than the reading you obtain) | 3% (12/400) | 5% (20/400) | 3% (12/400) |
| Misclassified lower risk (indicates the percentage of the time that your results could actually be higher than the reading you obtain) | 2% (8/400) | 3% (12/400) | 3% (12/400) |
iii.) Alternative testing sites for blood glucose measurement: Upper arm, forearm, calf, thigh, ventral palm and dorsal hand testing has been performed by the patients and the healthcare professionals to show comparable performance at times of steady state conditions. A venous whole blood sample was drawn at the same time and tested on the Hitachi 747 analyzer (comparative method). The range of glucose values for these samples was $60 - 600\mathrm{mg / dL}$ (by the finger), $\mathrm{N} = 150$ . The linear regressions were as follows:
Results by layusers:
| Alternate testing sites | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| Upper arm | 0.9904 | +3.2926 | 0.9882 |
| Forearm | 0.9962 | +0.5859 | 0.9870 |
| Calf | 0.9937 | +1.6113 | 0.9869 |
| Thigh | 0.9910 | +0.6124 | 0.9870 |
| Ventral palm | 0.9802 | +4.8658 | 0.9860 |
| Dorsal hand | 0.9776 | +4.6717 | 0.9887 |
Based on the ISO Standard 15197 document, how well the alternative testing by layusers compared with the laboratory method using Hitachi 747 is shown in the tables below:
1. Layuser test results of DORSAL HAND were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
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| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 112/145 (77%) | 143/145 (99%) | 145/145 (100%) | 145/145 (100%) |
2. Layuser test results of VENTRAL HAND were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 111/145 (77%) | 143/145 (99%) | 145/145 (100%) | 145/145 (100%) |
3. Layuser test results of UPPER ARM were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 109/145 (75%) | 143/145 (99%) | 145/145 (100%) | 145/145 (100%) |
4. Layuser test results of FORE ARM were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 95/145 (66%) | 137/145 (94%) | 143/145 (99%) | 145/145 (100%) |
5. Layuser test results of THIGH were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 3/5 (60%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 103/145 (66%) | 137/145 (94%) | 144/145 (99%) | 145/145 (100%) |
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6. Layuser test results of CALF were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 2/5 (40%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 100/145 (69%) | 138/145 (95%) | 145/145 (100%) | 145/145 (100%) |
Results by professionals:
| Alternate testing sites | Slope | Intercept | R2 |
| --- | --- | --- | --- |
| Upper arm | 0.9834 | +3.5744 | 0.9902 |
| Forearm | 1.0033 | -2.6804 | 0.9906 |
| Calf | 1.0068 | +1.0927 | 0.9922 |
| Thigh | 0.9814 | +3.044 | 0.9908 |
| Ventral palm | 0.9994 | +0.0632 | 0.9936 |
| Dorsal hand | 0.9848 | +3.2449 | 0.9931 |
Based on the ISO Standard 15197 document, how well the alternative testing by professionals compared with the laboratory method using Hitachi 747 is shown in the tables below:
1. Professionals test results of DORSAL HAND were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 5/5 (100%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 108/145 (74%) | 141/145 (97%) | 145/145 (100%) | 145/145 (100%) |
2. Professionals test results of VENTRAL HAND were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 122/145 (84%) | 145/145 (99%) | 145/145 (100%) | 145/145 (100%) |
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3. Professionals test results of UPPER ARM were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 105/145 (72%) | 142/145 (99%) | 145/145 (100%) | 145/145 (100%) |
4. Professionals test results of FORE ARM were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 106/145 (73%) | 142/145 (98%) | 145/145 (99%) | 145/145 (100%) |
5. Professionals test results of THIGH were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 4/5 (80%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 104/145 (72%) | 140/145 (97%) | 145/145 (99%) | 145/145 (100%) |
6. Professionals test results of CALF were compared to the laboratory method.
| System accuracy results for glucose concentration <75 mg/dL | | |
| --- | --- | --- |
| Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15mg/dL |
| 5/5 (100%) | 5/5 (100%) | 5/5 (100%) |
| System accuracy results for glucose concentration ≥75 mg/dL | | | |
| --- | --- | --- | --- |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 114/145 (79%) | 141/145 (97%) | 145/145 (100%) | 145/145 (100%) |
Note: When meter results are compared to the laboratory results, results below 75 mg/dL are compared in mg/dL.
{24}
b. Matrix comparison:
None
The sponsor only claimed capillary whole samples to be used with the device.
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):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The normal fasting adult glucose range for a non-diabetic is 70 – 110 mg/dL¹. Two hours after a meal, normal blood glucose levels should be less than 140 mg/dL².
References:
1. Stedman’s Medical Dictionary 27th Edition
2. American Diabetes Association Clinical Practice
*The NCEP ATP III guidelines suggest the following classifications:
| Total Cholesterol: | <200 mg/dL | Desirable |
| --- | --- | --- |
| | 200-239 mg/dL | Borderline High |
| | ≥240 mg/dL | High |
| HDL Cholesterol: | <40 mg/dL | Low |
| | ≥ 60 mg/dL | High |
| LDL Cholesterol: | <100 mg/dL | Optimal |
| | 100-129 mg/dL | Near Optimal |
| | 130-159 mg/dL | Borderline High |
| | 160-189 mg/dL | High |
| | ≥190 mg/dL | Very High |
{25}
Triglycerides: <150 mg/dL Normal
150-199 mg/dL Borderline High
200-499 mg/dL High
≥500 mg/dL Very High
*The National Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)
- NIH, May 2001
## N. Instrument Name:
LipidPro™ meter
## O. System Descriptions:
1. Modes of Operation:
Each test strip is single use and must be replaced with a new strip for additional readings. There are two separate test strip insertion ports. The glucose strip measurement connector is at the top part of the meter and the lipid strip inserting part is at the bottom part of the meter. The glucose sample volume is 0.3μl while the lipid sample volume is 5 μl.
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, ventral palm, dorsal hand, forearm, upper arm, calf, and thigh only. The whole blood sample is applied directly to the test strip by capillary action. Venous EDTA samples may be used by the healthcare professionals.
The lipid tests are intended to be used with capillary whole blood from the finger. A capillary rod is used to pick up the blood samples before applying onto the test strips. Venous EDTA and heparin samples may be used by the healthcare professionals.
{26}
27
5. Calibration:
There is no calibration required for the LipidPro meter by the user; however, the user must check to make sure the code number of the test strip matches the code number displays on the meter before running any test. There are two ways to code the meter: The glucose test strip has a color-tag at the back of the strip which enables the meter to recognize its code number through the RFID tag on the meter. The lipid test strip has a RFID-tag on each test strip’s vial which enables the meter to recognize its code.
The LipidPro glucose measuring test system is plasma-calibrated.
6. Quality Control:
Glucose control solutions at three different concentrations and lipids control solutions at two different concentrations can be run with this device. The user must select the control mode using the mode button to prevent control results from being stored in the internal memory as patient result. 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 test strip vial label. The user is cautioned not to use the meter if the control result falls outside these ranges.
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 100 lay users (aged 18-70 yrs old) who were provided with the test kit containing labeling for the US market. Participants varied in age, education, country of origin, and were about evenly divided between men and women. These lay users also completed a questionnaire to response to whether the device is easy to use and the Instructions for use were written in a way that makes it easy to use. The sponsor concluded that 100% of the users responded that both the device and Instructions for use were easy to use.
2. Flesch-Kincaid readability assessment was conducted and the sponsor concluded that a 7th grader would be able to read all the package inserts and user manual according to the Flesch-Kincaid grade levels.
3. Customer service is available 24/7, 365 days a year. Toll free phone number is 1-888-446-3246 for customer support.
4. EMC testing was performed and passed by the SK TECH Co. and a certificate to Infopia Co., was provided by the sponsor.
{27}
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.
28
