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The Randox Laboratories Limited Apolipoprotein Calibrator is based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level. The Randox Labotatories Limited Apolipoprotein Calibrator should only be used by suitably qualified personnel, under appropriate laboratory conditions.

Based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations are present at 1 level.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "APOLIPOPROTEIN CALIBRATOR." This type of document does not contain the detailed study results, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive premarket submission.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" to a legally marketed predicate device, but does not provide specific performance metrics or acceptance criteria for this particular calibrator.
• Sample size used for the test set and the data provenance: Not available in this document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
• Adjudication method for the test set: Not available in this document.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are typically for imaging devices or those requiring human interpretation, which is not the case for a calibrator. This information is not available.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a calibrator.
• The type of ground truth used: Not available for a calibrator in this context.
• The sample size for the training set: Not applicable or available for a calibrator.
• How the ground truth for the training set was established: Not applicable or available for a calibrator.

What the document does tell us:

• Device Name: APOLIPOPROTEIN CALIBRATOR
• Manufacturer: Randox Laboratories, Ltd.
• Indications For Use: "The Randox Laboratories Limited Apolipoprotein Calibrator is based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level."
• Regulatory Class: Class II (Special Controls)
• Product Code: JIX
• Nature of the Device: It is a calibrator, meaning it's used to establish the reference points for an assay that measures Apolipoprotein A-1 and Apolipoprotein B in human serum. Its primary function is to ensure the accuracy and reliability of these assays. The review by the FDA determined it was "substantially equivalent" to a predicate device already on the market.

To obtain the detailed performance data and acceptance criteria, one would typically need to review the full 510(k) submission, which is generally not publicly available in its entirety, or the device's labeling and instructions for use, which might contain more specific performance claims if required.

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