(74 days)
Phosphotungstic Acid MgCly (PTA) precipitation method
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No
The device description and performance studies focus on a chemical assay method for determining HDL cholesterol levels, with no mention of AI or ML.
No
Explanation: The device is an in-vitro diagnostic test kit used for the quantitative determination of HDL-C in human serum and plasma, which is a diagnostic function, not therapeutic.
Yes
The device is described as a "kit...for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma." The quantitative determination of a biomarker (HDL-C) in a biological sample is a characteristic of a diagnostic device.
No
The device is a chemical reagent kit used for laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma." This involves testing biological samples (serum and plasma) in vitro (outside the body) to obtain diagnostic information (HDL-C levels).
- Device Description: The description details a method for analyzing components within human serum and plasma using reagents and enzymatic reactions. This is a characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing human serum samples and comparing the results to reference methods, which is standard practice for validating IVD devices.
- Intended User/Care Setting: The intended user is a "clinical laboratory setting," which is where IVD tests are typically performed.
The core function of the device is to analyze a biological sample in vitro to provide information about a patient's health status (HDL-C levels are used in assessing cardiovascular risk), which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Genzyme N-geneousTM HDL Cholesterol Kit is for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.
Product codes
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Device Description
The Genzyme N-geneousTM 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 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 cholesterol enzymes. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Comparative performance studies were conducted at three sites using the N-geneous™ HDL Cholesterol Kit and two reference methods: Phosphotungstic Acid MgCly (PTA) precipitation method and the Center for Disease Control (CDC) reference method. Based on the Lipid Research Clinics (LRC) population studies, patient serum samples with HDL values between 27-91 mg/dL (5th and 95th percentile) were used for these comparative studies.
One hundred fourteen serum samples, with HDL values between 24 and 94 mg/dL, were tested at three sites with the N-geneous™ HDL test method. Of these 114 samples, 108 had sufficient volume for testing with the PTA predicate method. Additionally, a subset of at least 25 serum samples were analyzed by the CDC reference method and the results compared.
N-geneous™ vs. Phosphotungstic Acid (n = 108):
Correlation Coefficient (r): 0.96
Regression Equation: y = 0.81x + 7.82
N-geneous™ vs. CDC Method (n = 26):
Correlation Coefficient (r): 0.96
Regression Equation: y = 1.01x - 3.39
Precision studies were conducted using the N-geneous™ HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using fresh and frozen serum pools at three target levels of HDL Cholesterol as determined by the NCEP: 60 mg/dL (high).
Within-Run Precision:
Low (60 mg/dL): n=20, Mean=75.6 mg/dL, SD=0.79 mg/dL, %CV=1.04%
Between-Run Precision:
Low (60 mg/dL): n=80, Mean=73.2 mg/dL, SD=2.03 mg/dL, %CV=2.78%
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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ATTACHMENT 1
510(k) Summary Of Safety and Effectiveness Information Upon Which An Equivalence Determination Could be Made
| Trade or Proprietary Name: | Genzyme N-geneousTM HDL Cholesterol Kit |
|---|---|
| Common or Usual Name: | Homogeneous assay for high density lipoprotein cholesterol |
| Calibrator for high density lipoprotein cholesterol | |
| Classification Name: | High density lipoprotein cholesterol test |
| Calibrator, Primary | |
| Manufacturer: | Genzyme Diagnostics |
| One Kendall Square | |
| Cambridge, MA 02139-1562 | |
| Contact Person: | Nancy E. Isaac, Associate Director, Regulatory Affairs (617) 374-7431 or |
| Beth A. Crowley, Regulatory Associate, (617) 252-7669. |
The use of the Genzyme N-geneous™ HDL Cholesterol Kit in the clinical laboratory setting is substantially equivalent to the Phosphotungstic Acid MgCly (PTA) precipitation method.
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.
Comparative performance studies were conducted at three sites using the N-geneous™ HDL Cholesterol Kit and two reference methods: Phosphotungstic Acid MgClo and the Center for Disease Control (CDC) reference method. Based on the Lipid Research Clinics (LRC) population studies, patient serum samples with HDL values between 27-91 mg/dL (5th and 95th percentively) were used for these comparative studies.
One hundred fourteen serum samples, with HDL values between 24 and 94 mg/dL, were tested at three sites with the N-geneous™ HDL test method. Of these 114 samples, 108 had sufficient volume
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for testing with the PTA predicate method. Additionally, a subset of at least 25 serum samples were Und i to be analyzed by the CDC reference method and the results compared.
| | N-geneous™ vs.
Phosphotungstic Acid
(n = 108) | N-geneous™ vs.
CDC Method
(n = 26) |
|-----------------------------|-----------------------------------------------------|------------------------------------------|
| Correlation Coefficient (r) | 0.96 | 0.96 |
| Regression Equation | $y = 0.81x + 7.82$ | $y = 1.01x - 3.39$ |
Precision studies were conducted using the N-geneous™ HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using fresh and frozen serum pools at three target levels of HDL Cholesterol as determined by the NCEP: 60 mg/dL (high).
| Within-Run | Low
(60 mg/dL) |
|--------------|--------------------|----------------------|---------------------|
| n | 20 | 20 | 20 |
| Mean (mg/dL) | 30.2 | 42.7 | 75.6 |
| SD (mg/dL) | 0.45 | 0.50 | 0.79 |
| %CV | 1.50% | 1.18% | 1.04% |
| Between-Run | Low
(60 mg/dL) |
|--------------|--------------------|----------------------|---------------------|
| n | 80 | 80 | 80 |
| Mean (mg/dL) | 29.4 | 41.9 | 73.2 |
| SD (mg/dL) | 1.11 | 1.10 | 2.03 |
| %CV | 3.79% | 2.64% | 2.78% |
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.
In lieu of a 510(k) statement under 513(i) of the Act, this information is provided as a 510(k) summary for disclosure to any other persons/companies without the specific written authorization from Genzyme Corporation.