(77 days)
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Not Found
No
The device description and performance studies focus on a chemical assay method for measuring HDL-C, with no mention of AI or ML technologies.
No
This device is for in vitro diagnostic use, specifically for the quantitative determination of HDL-C, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "for in vitro diagnostic use" for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in human serum and plasma. This indicates its use in diagnosing or monitoring health conditions.
No
The device description clearly states it is a "two-reagent homogeneous method" and a "Kit," indicating it includes physical reagents and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "for in vitro diagnostic use." in the Intended Use section.
- The device description details a method for the "quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma," which are biological samples tested in vitro.
- The performance studies involve testing human serum samples.
N/A
Intended Use / Indications for Use
for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) n human serum and plasma.
for in vitro diagnostic use.
for the calibration of the Liquid N-geneous HDL Cholesterol assay.
for in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LBS, JIS
Device Description
The Genzyme Liquid N-geneous™ HDL Cholesterol Kit is a two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.
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 and physician's office laboratory settings
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the Liquid N-geneous™ HDL Cholesterol Kit and two reference methods: Sodium Phosphotungstate MgCly and the Center for Disease Control (CDC) designated comparison method (DCM). When samples contained triglyceride levels >200 mg/dL, the HDL reference method (ultracentrifugation, chemical precipitation and Abell-Kendall) was performed. 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.
Ninety two serum samples, with HDL values between 25 and 91 mg/dL, were tested at Genzyme Corporation using the Liguid N-geneous™ HDL and the PTA precipitation methods. Of these 92 samples, 54 were tested with the CDC Designated Comparison Method for samples with trighyceride levels 200 mg/dL.
Precision studies were conducted using the Liquid N-geneous™ HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using frozen serum pools at three target levels of HDL cholesterol as determined by the National Cholesterol Education Program (NCEP): 60 mg/dL (high).
- Within-Run (n=20 for each level):
- Low (60 mg/dL): Mean 84.7 mg/dL, SD 0.24 mg/dL, %CV 0.28
- Between-Run (n=40 for each level):
- Low (60 mg/dL): Mean 85.6 mg/dL, SD 1.00 mg/dL, %CV 1.17
In separate comparative performance studies, three physician office laboratories (POL) analyzed separate sets of 40 serum samples using the lyophilized format of Genzyme's N-geneous™ HDL Cholesterol Reagent Kit. Split samples from the same 40 specimens were also analyzed at Genzyme, which acted as the reference laboratory.
Precision studies were conducted using the Ivophilized N-geneous™ HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using frozen serum pools at three target levels of HDL cholesterol as determined by the National Cholesterol Education Program (NCEP): 60 mg/dL (high). It was determined that each POL site achieved the NCEP goals of CVs =42 mg/dL, and
§ 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.
0
510(k) PREMARKET NOTIFICATION
Cambridge, MA 02139
June 16, 1997
Liquid N-geneous™ HDL
Cholesterol Reagent Kit
March 28, 1997
ATTACHMENT 1
510(k) Summary Of Safety and Effectiveness Information Upon Which An Equivalence Determination Could be Made
| Trade or Proprietary Name: | Genzyme Liquid N-geneous™ HDL Cholesterol Kit |
|---|---|
| Common or Usual Name: | Homogeneous assay for high density lipoprotein |
| cholesterol | |
| Classification Name: | High density lipoprotein cholesterol test |
| 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 Liquid Genzyme N-geneous™ HDL Cholesterol Kit in clinical and physician's office laboratory settings is substantially equivalent to the Sodium Phosphotungstate MgCl2 (PTA) method. The Genzyme Liquid N-geneous™ HDL Cholesterol Kit is a two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.
In both user settings, the principle of the test is based upon a unique detergent which selectively solubilizes only the HDL. This unique detergent also strongly inhibits the reaction of the enzymes with cholesterol contained in the low density lipoprotein (LDL), very low density lipoprotein (VLDL) and chylomicron particles. Consequently, only the cholesterol in the resultant micell complexes of the detergent and lipids is subject to the enzyme reactions, leading to the selective determination of HDL cholesterol.
Comparative performance studies were conducted using the Liquid N-geneous™ HDL Cholesterol Kit and two reference methods: Sodium Phosphotungstate MgCly and the Center for Disease Control (CDC) designated comparison method (DCM). When samples contained triglyceride levels >200 mg/dL, the HDL reference method (ultracentrifugation, chemical precipitation and Abell-Kendall) was performed. 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.
1
Ninety two serum samples, with HDL values between 25 and 91 mg/dL, were tested at Genzyme Corporation using the Liguid N-geneous™ HDL and the PTA precipitation methods. Of these 92 samples, 54 were tested with the CDC Designated Comparison Method for samples with trighyceride levels 200 mg/dL.
| Liquid N-geneous™ HDL | vs.
Phosphotungstate
(n = 92) | vs.
CDC Method
(n = 54) |
|-----------------------------|-------------------------------------|-------------------------------|
| Slope | 0.960 | 1.056 |
| Intercept (mg/dL) | 3.97 | -0.736 |
| Correlation Coefficient (r) | 0.991 | 0.992 |
| Mean (mg/dL) | Ng: 51.3
PTA: 49.3 | Ng: 54.3
CDC: 52.0 |
| Standard Deviation (mg/dL) | Ng: 13.7
PTA: 14.1 | Ng: 12.2
CDC: 11.5 |
| Mean Difference (mg/dL) | 2.0 | 2.2 |
| Mean Percent Difference | 4.7% | 4.1% |
Precision studies were conducted using the Liquid N-geneous™ HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using frozen serum pools at three target levels of HDL cholesterol as determined by the National Cholesterol Education Program (NCEP): 60 mg/dL (high).
| Within-Run | Low
(60 mg/dL) |
|----------------------|--------------------|----------------------|---------------------|
| n | 20 | 20 | 20 |
| Sample Range (mg/dL) | 22.6 - 23.5 | 55.1 - 56.7 | 84.3 - 85.0 |
| Mean (mg/dL) | 22.9 | 55.8 | 84.7 |
| SD (mg/dL) | 0.23 | 0.44 | 0.24 |
| %CV | 0.99 | 0.79 | 0.28 |
| Between-Run | Low
(60 mg/dL) |
|----------------------|--------------------|----------------------|---------------------|
| n | 40 | 40 | 40 |
| Sample Range (mg/dL) | 22.6 - 24.1 | 54.5 - 57.1 | 83.7 - 87.8 |
| Mean (mg/dL) | 23.4 | 55.7 | 85.6 |
| SD (mg/dL) | 0.35 | 0.73 | 1.00 |
| %CV | 1.49 | 1.31 | 1.17 |
In separate comparative performance studies, three physician office laboratories (POL) analyzed separate sets of 40 serum samples using the lyophilized format of Genzyme's N-geneous™ HDL Cholesterol Reagent Kit. Split samples from the same 40 specimens were also analyzed at
2
Genzyme, which acted as the reference laboratory. The correlation coefficient between the reference testing site and the POL testing sites for this study were:
| Parameter | Site #1 | Site #2 | Site #3 |
|---|---|---|---|
| Slope | 1.11 | 1.12 | 0.93 |
| Intercept (mg/dL) | -1.44 | -5.90 | 1.25 |
| Correlation Coefficient (r) | 0.97 | 0.99 | 0.99 |
In the same study, the three POL sites compared their Genzyme N-geneous™ HDL Cholesterol Reagent Kit results to their respective current HDL methods for each of these 40 patient samples. The correlation coefficient for these comparisons were:
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Precision studies were conducted using the Ivophilized N-geneous™ HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using frozen serum pools at three target levels of HDL cholesterol as determined by the National Cholesterol Education Program (NCEP): 60 mg/dL (high). It was determined that each POL site achieved the NCEP goals of CVs ≤6% at ≥42 mg/dL, and ≤2.5 mg/dL SD at