N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

K962186 · Genzyme Corp. · LBR · Aug 19, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962186
• Device Name: N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
• Applicant: Genzyme Corp.
• Product Code: LBR · Clinical Chemistry
• Decision Date: Aug 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

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.

Device Story

The N-geneous™ HDL Cholesterol Kit is a two-reagent homogeneous assay for clinical laboratory use. It measures HDL cholesterol in human serum or plasma. Principle: Reagent 1 contains polymers and polyanions that bind to and stabilize LDL, VLDL, and chylomicrons. Reagent 2 contains detergent and cholesterol enzymes; the detergent solubilizes only the unstabilized HDL particles, allowing cholesterol enzymes to react specifically with HDL cholesterol. The resulting signal is measured to quantify HDL-C levels. This direct method eliminates the need for manual precipitation steps required by traditional methods. Results assist clinicians in assessing lipid profiles and cardiovascular risk.

Clinical Evidence

Bench testing only. Comparative study of 108 samples vs. PTA method (r=0.96) and 26 samples vs. CDC reference method (r=0.96). Precision studies performed at three target levels (<35, 35-60, >60 mg/dL) with within-run CVs of 1.04-1.50% and between-run CVs of 2.64-3.79%.

Technological Characteristics

Two-reagent homogeneous enzymatic assay. Reagent 1: polymers and polyanions. Reagent 2: detergent and cholesterol enzymes. Quantitative colorimetric measurement. Standalone clinical laboratory diagnostic kit.

Indications for Use

Indicated for the direct quantitative determination of HDL cholesterol in human serum and plasma for clinical laboratory use.

Regulatory Classification

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.

Predicate Devices

• Phosphotungstic Acid MgCl2 (PTA) precipitation method

Reference Devices

• Center for Disease Control (CDC) reference method

Submission Summary (Full Text)

{0}

510(k) PREMARKET NOTIFICATION
N-geneous™ HDL Cholesterol Kit
Summary of Safety and Effectiveness
June 5, 1996

Genzyme Corporation
One Kendall Square
Cambridge, MA 02139

K962186

# 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
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 [phone] or Beth A. Crowley, Regulatory Associate, [phone].

The use of the Genzyme N-geneous™ HDL Cholesterol Kit in the clinical laboratory setting is substantially equivalent to the use of the Phosphotungstic Acid $\mathrm{MgCl}_2$ (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 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.

Comparative performance studies were conducted at three sites using the N-geneous™ HDL Cholesterol Kit and two reference methods: Phosphotungstic Acid $\mathrm{MgCl}_2$ 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, respectively) 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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{1}

510(k) PREMARKET NOTIFICATION
N-geneous™ HDL Cholesterol Kit
Summary of Safety and Effectiveness
June 5, 1996
Genzyme Corporation
One Kendall Square
Cambridge, MA 02139
4462186

for testing with the PTA predicate method. Additionally, a subset of at least 25 serum samples were 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: &lt;35 mg/dL (low); 35-60 mg/dL (mid); and &gt;60 mg/dL (high).

| Within-Run | Low (<35 mg/dL) | Mid (35-60 mg/dL) | High (>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 (<35 mg/dL) | Mid (35-60 mg/dL) | High (>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.

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