K Number
K971190
Device Name
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
Manufacturer
Date Cleared
1997-06-16

(77 days)

Product Code
Regulation Number
862.1475
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
More Information

Not Found

No
The device description and performance studies focus on chemical reactions and standard statistical analysis, with no mention of AI or ML terms or concepts.

No.
This device is an in vitro diagnostic product designed for quantitative determination of HDL cholesterol, not for therapeutic purposes.

Yes

The device "is an in vitro diagnostic product" for the quantitative determination of HDL cholesterol in human serum or plasma, which is used for diagnostic purposes in a clinical laboratory setting.

No

The device description clearly states it is an "in vitro diagnostic product" and describes chemical reagents and their interactions with biological samples, indicating it is a hardware-based diagnostic kit, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use / Indications for Use: The document explicitly states "For in vitro diagnostic use" multiple times in the intended use section.
  • Device Description: The description refers to the kit as "an in vitro diagnostic product".
  • FDA Clearance: It mentions FDA clearance with a reference number (K962186), which is a process for IVD devices.

N/A

Intended Use / Indications for Use

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.

Product codes

LBS, JIS

Device Description

The Genzyme N-geneous™ HDL Cholesterol Kit is a homogenous assay applicable to clinical chemistry analyzers that can accomodate two-reagent systems and does not require any off-line sample pretreatment or centrifugation steps.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician's office laboratory, clinical laboratory

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Comparative performance studies: Three physician office laboratories (POL) analyzed 40 serum samples using the N-geneous™ HDL Cholesterol Reagent Kit. Split samples from the same 40 specimens were also analyzed at Genzyme, which acted as the reference laboratory. In the same study, the three POL sites compared their Genzyme N-geneous™ HDL Cholesterol Reagent Kit results to their respective current Sodium Phosphotungstate MgCly method (PTA) for each of these 40 patient samples.

Precision studies: 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).

Key results: The correlation coefficient between the reference testing site and the POL testing sites for the 40 serum samples ranged from 0.97 to 0.99. The correlation coefficients for the comparison between the N-geneous™ HDL Cholesterol Reagent Kit and the Sodium Phosphotungstate MgCl2 method ranged from 0.97 to 0.99. 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

§ 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

-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 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

The use of the Genzyme N-geneous™ HDL Cholesterol Kit in the physician's office laboratory setting is substantially equivalent to the N-geneous™ HDL Cholesterol Kit when used in a clinical laboratory. 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 present clinical laboratory setting is

Beth A. Crowlev, Requlatory Associate (617) 252-7669.

In both user settings, the Genzyme N-geneous™ HDL Cholesterol Kit is a homogenous assay applicable to clinical chemistry analyzers that can accomodate two-reagent systems and does not require any off-line sample pretreatment or centrifugation steps.

being expanded to include physician office laboratories.

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.

In comparative performance studies, three physician office laboratories (POL) analyzed 40 serum samples using the N-geneous™ HDL Cholesterol Reagent Kit. Split samples from the same 40 specimens were also analyzed at Genzyme, which acted as the reference laboratory. The correlation coefficient between the reference testing site and the POL testing sites for this study were:

1

K971190

510(k) PREMARKET NOTIFICATION

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Correlation (

Coetticient (r)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

In the same study, the three POL sites compared their Genzyme N-geneous™ HDL Cholesterol Reagent Kit results to their respective current Sodium Phosphotungstate MgCly method (PTA) for each of these 40 patient samples. The correlation coefficient for these comparisons were:

ParameterSite #1Site #2Site #3
Slope0.881.050.77
Intercept (mg/dL)2.90-1.3211.1
Correlation Coefficient (r)0.970.990.98

Precision studies were conducted using the 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