(21 days)
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The BioScanner Plus (CardioChek brand) analyzer is intended to be used by healthcare professionals to measure blood analytes on a test strip. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The Lipid Panel Test Strips are dry phase test strips that are constructed from a plastic strip holder that holds chemically treated membranes. When whole blood is placed on the test strip, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membrane and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus (CardioChek brand) reflectance photometer.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested formatting:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Lot Homogeneity) | 10% CV | Improved (beyond original 15% CV) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "scale-up of the process to manufacture larger lots of the test strips" and "increase in manufacturing experience," which led to improved precision. However, specific details about the data collected for this precision study are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) test strip that measures analytes directly. Ground truth would typically be established through reference laboratory methods rather than expert consensus on images or clinical assessments. The document does not mention the use of experts for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, ground truth for IVD devices is typically established through a reference method, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test strip and not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, if we interpret "standalone" as the performance of the device itself (the test strip and analyzer) without human interpretive input for the measurement. The study focuses on the "precision performance" of the test strips, which is an intrinsic characteristic of the device.
7. The Type of Ground Truth Used
The type of "ground truth" used would be the actual concentrations of cholesterol, HDL cholesterol, and triglycerides in the whole blood samples, as determined by a reference method (though the specific reference method is not stated, it is implied for an IVD device measuring these analytes). The study measured the precision of the device against these true values.
8. The Sample Size for the Training Set
Not applicable. This device is a dry phase test strip that relies on chemical reactions for measurement, not a machine learning algorithm that requires a training set. The "improvements" noted are due to manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.