(218 days)
The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Trighcerides measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.
Use this product at the frequency your doctor recommends for testing Total Cholesterol, and Triglycerides.
An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are
Over the Counter (home use): The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution and is intended to be used by a single person and should not be shared.
The Mission Cholesterol Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary whole blood from the fingertip. The Mission Cholesterol Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.
Professional: The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter. Mission Cholesterol Pro Test Cartridges. Mission Cholesterol Pro Optical Verifier and Mission Cholesterol Pro Control Solution and is intended for professional use in healthcare settings for multiple patient uses.
The Mission Cholesterol Pro Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary and venous human whole blood. The Mission Cholesterol Pro Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.
Test Cartridge:
The Mission Cholesterol (Home use) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary whole blood from the fingertip. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.
The Mission Cholesterol Pro (Professional) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary and venous human whole blood. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.
Control Solution:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Control Solutions are used to estimate precision of meter readings for determination of total cholesterol (CHOL), high density lipoprotein cholesterol (HDL) and triglycerides (TRIG).
Optical verifier:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Optical Verifiers are used to verify that the meter functions properly by checking that the meter can detect a pre-calibrated value.
Here's a summary of the acceptance criteria and study findings for the Mission Cholesterol Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" values in a table. However, the linearity, precision, and bias data are direct measures of performance against presumed internal or regulatory benchmarks for acceptable accuracy and precision in cholesterol measurement devices. We will infer the reported device performance from the study results presented.
| Performance Metric | Acceptance Criteria (Implied/Industry Norms) | Reported Device Performance - Total Cholesterol | Reported Device Performance - HDL Cholesterol | Reported Device Performance - Triglycerides |
|---|---|---|---|---|
| Precision (Repeatability %CV) | Generally 0.90 for good correlation | 0.9846 | 0.9768 | 0.9934 |
| Correlation ($R^2$) - Professional, Finger Capillary | Typically >0.90 for good correlation | 0.9883 | 0.9778 | 0.9948 |
| Correlation ($R^2$) - Professional, Heparin Venous | Typically >0.90 for good correlation | 0.9863 | 0.9790 | 0.9936 |
| % Bias at Medical Decision Points (Finger Blood) | Generally within ±5-10% for clinical acceptability | (-0.1% at 200mg/dL, -0.1% at 240mg/dL) | (-0.3% at 40mg/dL, -0.1% at 60mg/dL) | (0.3% at 150mg/dL, 0.0% at 200mg/dL, -0.2% at 500mg/dL) |
| % Bias at Medical Decision Points (Venous Blood) | Generally within ±5-10% for clinical acceptability | (-0.7% at 200mg/dL, -0.8% at 240mg/dL) | (1.9% at 40mg/dL, 1.0% at 60mg/dL) | (-1.8% at 150mg/dL, -1.5% at 200mg/dL, -1.2% at 500mg/dL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 369 patients were recruited for the clinical study.
- Data Provenance: The study was conducted at three point-of-care (POC) sites located in different geographical locations. It is a prospective clinical study as patients were recruited and tested specifically for this study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be compliant with US regulatory standards, likely involving data collected within the US or under equivalent standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts. However, it mentions:
- "For professional use, patient blood was collected from fingertip and venous blood draws. Capillary blood samples from fingertip were tested at clinical sites by professionals. Venous blood samples were tested at a laboratory using an FDA cleared method."
- "The plasma concentration was confirmed by the reference method."
This implies that trained "professionals" (likely medical technicians or laboratory personnel) performed the official comparative testing, and an FDA-cleared reference method was used to establish the ground truth. No specific number or qualification (e.g., "radiologist with 10 years of experience") for these "professionals" is given beyond their professional role in clinical sites or laboratories.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth was established by comparing the device's results to an "FDA cleared method" and a "reference method" in laboratory settings. This suggests direct quantitative comparison rather than a consensus-based adjudication process typical for qualitative or image-based diagnostics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of improving human reader performance with AI assistance. This study focuses on the device's standalone analytical performance compared to a reference method, and also includes layperson use, not assisted reading by human experts.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done for the device. The entire clinical study, comparing the Mission Cholesterol Monitoring System's measurements against a reference method, evaluates the algorithm's performance. Both professional operators and laypersons used the device independently to obtain results, which were then compared to the established ground truth.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparing the device's results to an FDA cleared method and a reference method (for plasma concentration).
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. The studies described are for the validation of an already developed device.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there's no information on how its ground truth would have been established. The provided document focuses on the validation of the device through performance and clinical studies.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.