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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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The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.

The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma. The first readent contains a mixture of polymers and polvanions that bind to the sufface 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 cholesterol enzymes. HDL particles, on the other hand, are not stabilized by the polymers and polvanions and become solubilized by the detergent. Consequently, only the HDL cholesterol is subject to cholesterol measurement.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the comparative performance studies, the implicit acceptance criteria for equivalence seem to be a high correlation coefficient and a regression equation demonstrating close agreement with the predicate methods. For precision, the acceptance criteria would be low %CV values, indicating good reproducibility.

The conclusion states, "These data demonstrate that the performance of the N-geneous™ HDL Cholesterol Kit in the clinical laboratory is substantially equivalent to the performance of the PTA and CDC Reference methods." This implies that the reported performance met the acceptance criteria for substantial equivalence.

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

• Comparative Studies (N-geneous™ vs. Phosphotungstic Acid):

  • Sample Size: 108 serum samples
  • Data Provenance: The document states "patient serum samples with HDL values between 27-91 mg/dL (5th and 95th percentively) were used for these comparative studies." This suggests the samples were from a clinical population. The studies were conducted at "three sites," implying real-world clinical settings. The data is retrospective as it uses pre-existing or collected patient samples. The country of origin is not explicitly stated.

• Comparative Studies (N-geneous™ vs. CDC Reference Method):

  • Sample Size: A subset of at least 25 serum samples (specifically, "n = 26" is reported in the table).
  • Data Provenance: Same as above – patient serum samples from the clinical population, likely retrospective, country of origin not specified.

• Precision Studies:

  • Sample Size: For within-run and between-run studies, 3 target levels (low, mid, high) were used.
    • Within-run: n=20 for each level (total 60 measurements on different aliquots of the same pool).
    • Between-run: n=80 for each level (total 240 measurements on different aliquots of the same pool over time).
  • Data Provenance: "fresh and frozen serum pools" were used. These are typically prepared in a laboratory setting. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable (N/A) / No Experts Used in this Context: For an in-vitro diagnostic (IVD) device like an HDL Cholesterol Kit, "ground truth" is established by a reference method or a predicate device, not by human expert interpretation in the same way it would be for imaging or clinical diagnosis.
  • The "experts" in this context are the established, validated laboratory methods themselves: the Phosphotungstic Acid MgCl (PTA) precipitation method and the Center for Disease Control (CDC) reference method for HDL-C.

4. Adjudication Method for the Test Set:

• Not Applicable (N/A): Adjudication, like 2+1 or 3+1, is typically used when human interpretation contributes to establishing ground truth for ambiguous cases, often in imaging studies. For an IVD, the reference methods provide definite numerical results, so no human adjudication of results is necessary. The comparison is entirely quantitative.

5. 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:

• No: This is an in-vitro diagnostic (IVD) device, not an AI-powered diagnostic imaging or clinical decision support tool that would involve human readers or AI assistance. Therefore, an MRMC study and analysis of human reader improvement with AI are not relevant or applicable here.

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

• Yes, by its nature: The "Genzyme N-geneous™ HDL Cholesterol Kit" is a standalone assay. It generates a numerical result (HDL-C concentration) directly from a serum/plasma sample without human interpretation or intervention in the measurement process itself, beyond performing the assay according to established protocols. Its performance figures (correlation, regression, precision) are entirely standalone.

7. The Type of Ground Truth Used:

• Reference Methods: The ground truth was established by two universally recognized and accepted reference methods for HDL-C measurement:
  • The Phosphotungstic Acid MgCl (PTA) precipitation method
  • The Center for Disease Control (CDC) reference method

8. The Sample Size for the Training Set:

• Not Applicable (N/A) / No Distinct Training Set: This device is a chemical assay, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense. The kit's reagents and protocol are developed through R&D and optimization, not by training on a dataset. The comparative and precision studies are for validation, not training.

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

• Not Applicable (N/A): As there is no training set in the sense of machine learning, this question does not apply. The "ground truth" for developing the assay itself would come from biochemical principles, chemical validation, and performance optimization against known standards and reference methods during its development phase.

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