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PTS PANELS HDL Cholesterol Test Strips are intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

PTS PANELS HDL Cholesterol Test Strips consist of chemical reagents in dry form. When whole blood is placed on the test strip, only the HDL cholesterol fraction passes through to the reaction layer. The HDL cholesterol reacts with a dried cholesterol reagent to produce color. The HDL concentration is proportional to the intensity of the color developed and is measured by a CardioChek brand analyzer.

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. It is a 510(k) summary for the PTS PANELS HDL Cholesterol Test Strips, focusing on its substantial equivalence to predicate devices and its intended use.

However, I can extract information related to the device and its intended use based on the provided text.

Here's an analysis of what is and is not available in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available: The document does not explicitly state acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds) nor does it provide detailed performance data from a specific study against such criteria. The "Measuring Range" of 25-85 mg/dL HDL Cholesterol is mentioned, but this is a device specification, not an acceptance criterion related to a study outcome.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Available: The document does not describe any specific test set, its sample size, or its provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Available: Since no specific clinical or performance study is detailed, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method:

• Not Available: No adjudication method is mentioned as there's no described study involving expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable/Not Available: This type of study is typically for image-based diagnostic aids involving human readers. The PTS PANELS HDL Cholesterol Test Strips are a dry chemistry test strip for quantitative measurement, not an imaging device requiring human interpretation in this context. Therefore, an MRMC study is not relevant, and no such study is described.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

• Partially Addressed by Nature of Device: The device itself is a standalone diagnostic tool, as it directly measures HDL cholesterol. However, the document does not describe a study explicitly proving its standalone performance against a defined set of acceptance criteria. The entire 510(k) submission process inherently evaluates the standalone performance of the device against predicate devices, but specific details of such a study (sample size, methods, results) are not in this summary.

7. Type of Ground Truth Used:

• Implied (Not Explicitly Stated for a Study): For a device like this, the "ground truth" would typically be established by a reference laboratory method (e.g., a standardized enzymatic assay or a CDC-certified method) against which the device's measurements are compared. The document states the "Chemistry Method" is "Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol," which suggests a well-established biochemical principle. However, it does not detail how this ground truth was applied in a specific performance study for the modified device.

8. Sample Size for the Training Set:

• Not Available: The document does not describe any training set or its sample size. This device is a chemical assay, not an AI/ML algorithm that typically requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable/Not Available: As no training set is described, there's no information on how its ground truth was established.

Summary of what is available from the document:

• Device Name: PTS PANELS HDL Cholesterol Test Strips
• Intended Use: To measure high density lipoprotein cholesterol in whole blood for the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.
• Technology: Dry chemistry test strip for use with PTS reflectance photometer.
• Measuring Range: 25-85 mg/dL HDL Cholesterol.
• Chemistry Method: Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.
• Key Modification: Change in chemistry fractionation method from Phosphotungstic acid precipitation to Dextran sulfate inhibiting method, and removal of glass fiber from the blood separation membrane.
• Predicate Devices: K990247 and K993377, the unmodified PTS PANELS HDL Cholesterol Test Strips from the same company.
• Regulatory Class: Class I.

To answer the prompt fully, more detailed study reports (e.g., analytical and clinical validation studies) would be required, which are typically found in the full 510(k) submission, not just the summary provided here. The provided text is a summary focusing on substantial equivalence to predicate devices, not a detailed performance study report.

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