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for the quantitative determination of high density lipoprotein (HDL) cholesterol in human serum or plasma. For in vitro diagnostic use. For the calibration of N-geneous HDL Cholesterol ass in serum or plasma. For in vitro diagnostic use.

The Genzyme N-geneous™ HDL Cholesterol Kit is an in vitro diagnostic product cleared (FDA Reference No. K962186) for use in the clinical laboratory for the quantitative determination of high density lipoprotein cholesterol in human serum or plasma. The first reagent contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent which is added as part of the second reagent, together with the remaining components of a cholesterol reagent. HDL particles, on the other hand, are not stabilized by the polymers and polyanions and become solubilized by the detergent. Consequently, only the HDL cholesterol is subject to cholesterol measurement.

Here's a breakdown of the acceptance criteria and study information for the Genzyme N-geneous™ HDL Cholesterol Reagent Kit, based on the provided 510(k) Premarket Notification:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the NCEP (National Cholesterol Education Program) goals for precision. No explicit numerical targets for correlation coefficients are provided, but the reported values demonstrate substantial equivalence.

Note on Acceptance Criteria: While the NCEP goals are explicitly stated for precision, the acceptance criteria for correlation are implied by the statement "These data demonstrate that the performance... is substantially equivalent." The high correlation coefficients (0.97-0.99) are presented as evidence of this equivalence.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 40 serum samples.
   • Data Provenance: The samples were "split samples" analyzed at three Physician's Office Laboratories (POLs) and Genzyme (reference lab). This indicates prospective collection relative to the study's comparison phase, but the original source/country of the patient samples is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the "ground truth" for the comparative performance study was established by a reference laboratory (Genzyme) using the same N-geneous™ HDL Cholesterol Kit, or by the POLs using their traditional Sodium Phosphotungstate MgCl2 method (PTA). No human experts were explicitly used for ground truth establishment in this context. The reference methods themselves serve as the comparative standard.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. The study involved direct comparison of quantitative results from different testing sites/methods, not interpretive adjudication of results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is an in vitro diagnostic device for chemical analysis (HDL cholesterol), not an imaging device requiring human readers or AI assistance in interpretation.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the performance characteristics (precision, and correlation against a reference method/site) were assessed for the N-geneous™ HDL Cholesterol Kit itself, which is a reagent kit used on clinical chemistry analyzers. This constitutes a standalone chemical assay performance assessment without a human interpretive "loop" altering the analytical result. The study focused on the performance of the kit in different laboratory settings.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Reference Method/Site Comparison:
     • For the comparison between POLs and the reference laboratory (Genzyme), the results from Genzyme using the N-geneous™ HDL Cholesterol Kit served as the reference standard.
     • For the comparison between the N-geneous™ HDL Cholesterol Kit and existing methods at the POLs, the "ground truth" were the results obtained by the POLs using their respective Sodium Phosphotungstate MgCl2 method (PTA). This is a comparison against an established, conventional method.
   • Precision: The NCEP goals for precision served as the benchmark. The "true" HDL cholesterol levels in the serum pools (low, mid, high) were determined by the assay itself.

7. The sample size for the training set:

   • Not applicable. This is an in vitro diagnostic device, not an AI or machine learning algorithm that requires a separate training set. The development of the reagents and assay methodology would involve internal R&D, but the submission describes validation studies, not AI model training.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set mentioned in the context of this 510(k) submission.

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