Search Results

PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

Dry chemistry test strip for use with PTS reflectance photometer. Single test strip with three tests.

The provided text describes a 510(k) submission for the PTS PANELS CHOL+HDL+GLU Panel Test Strips, which are intended to measure cholesterol, HDL cholesterol, and glucose in whole blood. However, the document does not contain the acceptance criteria or a study that specifically proves the device meets those criteria.

The document primarily focuses on:

• 510(k) Summary: Basic regulatory information, applicant details, device classification, intended use, and reason for submission (device modification).
• Predicate Device Information: Comparison of the modified device with its predicate devices, highlighting similarities in intended use, technology, storage, specimen type, chemistry method, and calibration. The key difference noted is that the modified device combines three tests into a single strip with a slightly longer overall result time (about two minutes for all three tests, compared to about one minute for each of three separate tests in the predicate).
• FDA Premarket Notification Letter: Official communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Detailed statement of how the device is intended to be used.

Based on the provided text, I cannot complete the requested information regarding acceptance criteria and the study that proves the device meets them, as this information is not present. The document states that the device is a modification of an existing device and that the FDA has determined it is substantially equivalent to legally marketed predicate devices. This suggests that the performance requirements might be similar to those of the predicate devices, but the specific acceptance criteria and the study design to demonstrate meeting them are not detailed here.

To answer your questions, I would need a different document, likely a "Performance Characteristics" or "Method Comparison Study" section, which is typically included in a 510(k) submission but is absent from the provided excerpt.

Ask a specific question about this device