(285 days)
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 LDLcholesterol values are reported only 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.
The LipidPro " system is a device which combines measuring systems for total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglyceride, and a blood glucose monitoring system into one convenient device. The glucose monitoring system function of the device utilizes Infopia's Evolution™ monitoring system cleared under K072369.
The LipidPro 10 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, TG tests) and glucose test respectively. The four types of the 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 following numerical formula. When TG is over 350 mg/dL, LDL is not calculated.
LDL=TC-HDL-(TG/5)
LipidPro " glucose test system is identical to the EVOLUTION™ glucose test system cleared under K072369. LipidPro™ glucose test strip is the same as the EVOLUTION™ glucose test strip except the cover printing design. Their size and components are the same. LipidPro™ glucose test meter is identical to the EVOLUTION " glucose test meter except the external design and having a lipid profile (TC/TG/HDL-C) test part on the other side of the meter. This does not affect to the safety and effectiveness for glucose test and data.
The test range of LipidPro TM system is 100-400mg/dL for total cholesterol, 25-80 mg/dL for HDLcholesterol. 70-600 mg/dL for Triglyceride and 20-600mg/dL for glucose. LDL cholesterol should be estimated from measurement of total cholesterol, HDL cholesterol and triglycerides.
LipidPro™ system has two kinds of test principle according to test items: one for glucose and the other for a lipid profile (TC, HDL-C, and TG).
Lipid profile test results are based on reading reflection density. When the blood is applied, the color changes in 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 deeper the color is, the higher the lipid level is.
Glucose in the blood sample will react to the electrodes in the glucose test strip, generating an electrical current that will stimulate a chemical reaction is measured by LipidPro™ meter and displayed as your blood glucose result.
The provided 510(k) summary for the Infopia LipidPro™ system contains limited information regarding specific acceptance criteria and the detailed study that proves the device meets these criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than rigorous performance metric reporting against predefined benchmarks.
However, based on the available text, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a structured table. Instead, it refers to "pass or fail criteria were based on the specifications cleared for the predicate device" and concludes with a qualitative statement of "substantial equivalence."
However, the "Comparison of Technological Characteristics with Predicate" section provides some implicit performance ranges that can be considered as the device's reported performance, and by extension, the acceptance criteria would be that the device operates within or acceptably close to these ranges as compared to the predicate.
| Measurement / Characteristic | LipidPro™ Lipid Measuring System Reported Performance | Predicate Device (PTS PANELS Lipid Panel Test Strips) Performance | (Implicit) Acceptance Criteria |
|---|---|---|---|
| Total Cholesterol (TC) | Test range: 100-400 mg/dL | Test range: 100-400 mg/dL | Performance within 100-400 mg/dL range and substantially equivalent to predicate device accuracy. |
| HDL-Cholesterol (HDL-C) | Test range: 25-80 mg/dL | Test range: 25-85 mg/dL | Performance within 25-80 mg/dL range and substantially equivalent to predicate device accuracy. |
| Triglyceride (TG) | Test range: 70-600 mg/dL | Test range: 50-500 mg/dL | Performance within 70-600 mg/dL range and substantially equivalent to predicate device accuracy. |
| Glucose | Test range: 20-600 mg/dL | Test range: 20-600 mg/dL | Performance within 20-600 mg/dL range and substantially equivalent to predicate device accuracy. |
| Hematocrit range (Lipid) | 30 ~55% | TC: 30 | Operates within relevant hematocrit ranges, demonstrating substantial equivalence. |
| Hematocrit range (Glucose) | 30 ~55% | 20~60% | Operates within relevant hematocrit ranges, demonstrating substantial equivalence. |
| Sample volume (Lipid) | 5 µl | 15 µl | Device performs with its stated sample volume, demonstrating at least equivalent performance to predicate's larger volume. |
| Sample volume (Glucose) | 0.3 µl | 0.3 µl | Device performs with its stated sample volume, demonstrating substantial equivalence. |
| Test time (Lipid) | 1-2 minutes | 1-2 minutes | Performance within 1-2 minutes. |
| Test time (Glucose) | 3 seconds | 3 seconds | Performance within 3 seconds. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The clinical performance evaluation using the LipidPro™ system was conducted for the purpose of validating the TC, HDL-C, LDL-C, TG, and Glucose measuring accuracy." However, it does not specify the sample size used for this clinical test set, nor does it provide information on the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "ground truth" implicitly as the reference measurements against which the device's accuracy was compared, but it does not detail how this ground truth was established or the experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported. The device is an in vitro diagnostic (IVD) measurement system, not an imaging or diagnostic aid that typically involves human reader interpretation. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was performed. The "clinical performance evaluation" assessed the LipidPro™ system's measuring accuracy for TC, HDL-C, LDL-C, TG, and Glucose. This evaluation measures the device's performance directly, independent of human interpretation or intervention beyond sample application. The conclusion states the device "performs as well as the legally marketed predicate device," indicating a standalone assessment.
7. Type of Ground Truth Used
The document does not explicitly state the specific "type" of ground truth used (e.g., pathology, outcomes data). However, for an in vitro diagnostic such as this, the ground truth would typically be established by high-precision laboratory reference methods (e.g., enzymatic assays performed on a clinical chemistry analyzer) for each analyte (Total Cholesterol, HDL-C, Triglyceride, Glucose) on the same blood samples. The "measuring accuracy" assessment implies a comparison against such reference methods.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For this type of IVD device, the development and calibration of the device's algorithms or enzymatic reactions would typically be done using internal development data. The reported "clinical performance evaluation" is usually considered the validation or test set.
9. How the Ground Truth for the Training Set Was Established
As no separate training set size is mentioned, the method for establishing its ground truth is also not described. For the internal development/calibration, the ground truth would be established through laboratory reference methods on well-characterized samples.
§ 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.