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The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. · visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Both the qualitative (presence of abnormal or absence of normal fractions) and semi-quantitative (relative increase or decrease of fractions) abnormalities necessitate further lipoprotein analyses. The procedure is indicated for the general population for determination of lipoprotein profiles.

The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. · visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for a device called "Hydragel 7 Lipoprotein(E) / Hydragel Lipoprotein(E) 15/30". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test sets or their data provenance.
• Details on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• If an MRMC comparative effectiveness study was done, or its effect size.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is primarily concerned with the regulatory clearance process based on substantial equivalence, not the detailed performance studies that would typically contain the information you are seeking.

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