(23 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. 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.
The Lipid Panel Test Strips are intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals and individuals at home to measure three blood analytes: cholesterol, HDL cholesterol and triglycerides. 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 mellitus, 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 a BioScanner Plus (CardioChek brand) reflectance photometer.
The provided text describes a 510(k) summary for a medical device called "PTS PANELS Lipid Panel Test Strips." However, it is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment studies.
The document primarily focuses on:
- Device Description: What the device is and how it generally works (dry phase test strips, reflectance photometer).
- Intended Use: What it's designed to measure (cholesterol, HDL cholesterol, triglycerides) and who can use it (healthcare professionals and individuals at home).
- Predicate Device Comparison: Similarities and differences with previously cleared devices.
- Regulatory Information: Classification, product codes, and the FDA's clearance letter.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The information you're asking for (acceptance criteria, performance data, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types for training and test sets) is typically found in the "Performance Data" or "Clinical Studies" sections of a 510(k) submission, which are not present in this summary.
The document states it's a "summary of safety and effectiveness information," but does not detail the specific studies conducted to demonstrate that safety and effectiveness.
§ 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.