(129 days)
The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Low HDL cholesterol is related to the high risk of coronary heart disease.
The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol-methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER). The enzymes selectively react with HDL to produce H2O2 which is detected through a Trinder reaction.
Here's a breakdown of the acceptance criteria and study information for the Diazyme HDL-Cholesterol Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined acceptance criteria in the form of thresholds. Instead, the "acceptance criteria" are implied by showing comparable performance to the predicate device.
| Performance Metric | Predicate Device (Ultra N-geneous HDL Cholesterol Reagent, K021316) | Diazyme HDL-Cholesterol Reagent | Comparison/Acceptance (Implied) |
|---|---|---|---|
| Linear Range (Serum) | 2.5 - 200 mg/dL | 1.06 - 184.8 mg/dL | Comparable (Slightly different, but within relevant clinical range and not considered a significant deviation by the FDA.) |
| Within-Run Precision (Serum) | 0.5% - 0.8% | 0.70% - 1.10% | Comparable (Slightly higher, but within acceptable limits for diagnostic assays.) |
| Total Precision (Serum) | 1.1% - 1.5% | 1.8% - 3.7% | Comparable (Slightly higher, but within acceptable limits for diagnostic assays.) |
| Correlation Coefficient (Accuracy/Serum) | 0.996 | 0.987 | Comparable (Indicates a strong correlation with the predicate device, supporting substantial equivalence.) |
| Slope/Intercept (Accuracy/Serum) | y = 0.99x + 2.81 mg/dL | y = 1.048x - 4.69 mg/dL | Comparable (The regression statistics are close to 1 for slope and 0 for intercept, indicating good agreement with the predicate.) |
| Interference (Triglycerides) | Not explicitly stated, implied to be acceptable | No interference at 1000 mg/dL | Acceptable |
| Interference (Ascorbic acid) | Not explicitly stated, implied to be acceptable | No interference at 10 mmol/L | Acceptable |
| Interference (Bilirubin) | Not explicitly stated, implied to be acceptable | No interference at 40 mg/dL | Acceptable |
| Interference (Bilirubin Conjugated) | Not explicitly stated, implied to be acceptable | No interference at 30 mg/dL | Acceptable |
| Interference (Hemoglobin) | Not explicitly stated, implied to be acceptable | No interference at 1000 mg/dL | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "samples tested with Diazyme HDL-Cholesterol Reagent showed good correlation with Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316) with correlation coefficients of 0.985 for serum samples." However, the exact number of samples used in the method comparison study (test set) is not specified.
- Data Provenance: The text refers to "clinical patient samples." It does not explicitly state the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For this in vitro diagnostic device, "ground truth" is established by comparison to a legally marketed predicate device, not through expert consensus on medical images or clinical outcomes. The predicate device itself serves as the benchmark.
4. Adjudication Method for the Test Set
- Not Applicable. Since ground truth is established by a predicate device's measurement, there is no expert adjudication process in this context. The comparison is a direct quantitative correlation between the results of the new device and the predicate device.
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
- Not Applicable. This is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging device. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance was done for the device itself. The performance characteristics (linearity, precision, accuracy, interference) are all intrinsic to the reagent's analytical capability, independent of a human "in the loop" for interpretation. The comparison is between the new reagent's measurements and those of the predicate reagent.
7. The Type of Ground Truth Used
- Predicate Device Measurement: The "ground truth" for evaluating the Diazyme HDL-Cholesterol Reagent is the results obtained from the Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316), which is a legally marketed predicate device. This is a form of comparison to a reference method, where the reference is an established and approved device. The predicate device itself measures the outcome (HDL-C concentration).
8. The Sample Size for the Training Set
- Not Applicable / Not Specified. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense. The development of the reagent involves chemical formulation and optimization, not data training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As explained above, there is no "training set" for this type of device. The development and validation process focuses on analytical performance characteristics and comparison to an established reference (the predicate device).
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.