(49 days)
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No
The device description details a chemical assay based on enzymatic reactions and colorimetric detection, with no mention of computational analysis or algorithms that would suggest AI/ML.
No
The device is a reagent used for diagnostic testing (measuring LDL-C levels) and does not directly provide therapy or treatment.
Yes
The device is described as a reagent for the "direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma," which is used to measure a specific biomarker. The determination of LDL-C levels is a diagnostic measure used to assess a patient's risk for cardiovascular disease.
No
The device description clearly indicates it is a reagent-based assay for measuring LDL cholesterol, which involves chemical reactions and laboratory procedures, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma." This indicates the device is used to analyze a sample taken from the human body (serum or plasma) to provide information about a medical condition (LDL-C levels).
- Device Description: The description details a "two-reagent homogeneous method" and "enzyme reaction" which are typical components and processes of in vitro diagnostic tests.
- Sample Type: The device is designed to be used with "human serum or plasma," which are biological samples taken from a patient.
- Clinical Laboratory Setting: The intended user/care setting is a "clinical laboratory setting," which is where IVD tests are typically performed.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device used to perform tests on samples taken from the human body to help diagnose, monitor, or treat medical conditions.
N/A
Intended Use / Indications for Use
Reagents: For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.
Calibrators: For the calibration of the N-geneous™ LDL Cholesterol assay in serum or plasma.
Controls: To monitor the performance of Genzyme LDL Cholesterol Reagents.
Product codes
LBR, JIS, JIS, JIX
Device Description
The Genzyme N-geneous™ LDL Cholesterol Reagent is a two-reagent homogeneous method for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum and plasma.
The principle of the test is based upon a unique detergent which selectively solubilizes only the non-L.DL lipoproteins, allowing them to be removed by cholesterol enzymes prior to the LDL cholesterol reaction. The LDL particles remain intact. The hydrogen peroxide produced by the reaction of the enzymes with the released cholesterol is consumed by a peroxidase reaction with 4-aminoantipyrine. yielding a colorless product. A second detergent, capable of releasing LDL cholesterol molecules, is added. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol in the sample.
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
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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 using the N-geneous™ LDL Cholesterol Reagents and two reference methods: Direct LDL Cholesterol Immunoseparation Reagent and 3-Quantification.
Ninety-two serum samples, with LDL values between 68.1 and 214.5 mg/dL, were tested at Genzyme Corporation using the N-geneous™ LDL and the Direct LDL methods. Of these 92 samples, 54 were tested with the ß-Quantification reference method.
Precision studies were conducted using the N-geneous™ LDL Cholesterol Reagents. Both within-run and between-run studies were performed using frozen serum pools at three target levels of LDL cholesterol as determined by the National Cholesterol Education Program (NCEP):
§ 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
Genzyme Corporation One Kendall Square Cambridge, MA 02139
June 18, 1997
Reagent and C
510(k) Summary Of Safety and Effectiveness Information Upon Which An Equivalence Determination Could be Made
| Trade or Proprietary Name: | Genzyme N-geneous™ LDL Cholesterol Reagent
Genzyme N-geneous™ LDL Cholesterol Calibrator
Genzyme LDL Control Set |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Homogeneous assay for low density lipoprotein cholesterol |
| Classification Name: | Low density lipoprotein cholesterol test
Calibrator, Primary
Low density lipoprotein control |
| 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 Affairs Associate (617) 252-7669 |
The use of the Genzyme N-geneous™ LDL Cholesterol Reagents in the clinical laboratory setting is substantially equivalent to the Direct LDL Cholesterol Immunoseparation Reagent and the B-Quantification methods.
The Genzyme N-geneous™ LDL Cholesterol Reagent is a two-reagent homogeneous method for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum and plasma.
The principle of the test is based upon a unique detergent which selectively solubilizes only the non-L.DL lipoproteins, allowing them to be removed by cholesterol enzymes prior to the LDL cholesterol reaction. The LDL particles remain intact. The hydrogen peroxide produced by the reaction of the enzymes with the released cholesterol is consumed by a peroxidase reaction with 4-aminoantipyrine. yielding a colorless product. A second detergent, capable of releasing LDL cholesterol molecules, is added. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol in the sample.
Comparative performance studies were conducted using the N-geneous™ LDL Cholesterol Reagents and two reference methods: Direct LDL Cholesterol Immunoseparation Reagent and 3-Quantification.
ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
1
510(k) PREMARKET NOTIFICATION
Ninety-two serum samples, with LDL values between 68.1 and 214.5 mg/dL, were tested at Genzyme Corporation using the N-geneous™ LDL and the Direct LDL methods. Of these 92 samples, 54 were tested with the ß-Quantification reference method.
| N-geneous™ LDL | vs.
β-Quantification
(n = 54) | vs.
Direct LDL
(n = 92) |
|-----------------------------|-------------------------------------|-------------------------------|
| Slope | 0.96 | 0.94 |
| Intercept | 3.02 | 4.46 |
| Correlation Coefficient (r) | 0.96 | 0.97 |
| Mean (mg/dL) | Ng: 122.5
βQ: 125.1 | Ng: 120.0
Dir: 122.8 |
| Standard Deviation (mg/dL) | Ng: 30.7
βQ: 30.9 | Ng: 30.5
Dir: 31.6 |
| Mean Difference | -2.62 | -2.81 |
| Mean Percent Difference | -1.9% | -2.0% |
Precision studies were conducted using the N-geneous™ LDL Cholesterol Reagents. Both within-run and between-run studies were performed using frozen serum pools at three target levels of LDL cholesterol as determined by the National Cholesterol Education Program (NCEP):