LFS LIPOGEL ASSAY KIT

K960785 · Zaxis, Inc. · JHO · Sep 3, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960785
• Device Name: LFS LIPOGEL ASSAY KIT
• Applicant: Zaxis, Inc.
• Product Code: JHO · Clinical Chemistry
• Decision Date: Sep 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

The LFS Lipogel Assay Kit is indicated for the electrophoretic separation of lipoproteins in a gradient polyacrylamide gel. That is, the LFS Lipogel Assay Kit is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions.

Device Story

LFS Lipogel Assay Kit performs electrophoretic separation of lipoproteins in human plasma or serum; utilizes gradient polyacrylamide gel; lipoproteins migrate in electrical field based on charge/size; fractions (HDL, VLDL, LDL, chylomicrons) immobilized in fixative; visualized via lipid-specific Sudan Black stain; densitometer used for quantification of relative percentages; used in clinical laboratory settings by trained personnel; results assist clinicians in lipid profile assessment.

Clinical Evidence

Bench testing only. Evaluated within-run and between-run reproducibility, and inter-laboratory reproducibility. Comparative performance study conducted against Helena Laboratories' Titan Gel-Lipoprotein Electrophoresis System (K833611). Data demonstrate substantial equivalence in separation and quantification of lipoprotein fractions.

Technological Characteristics

In vitro diagnostic system for electrophoresis. Components: gradient polyacrylamide gels, reagents, and electrophoresis hardware. Principle: electrical field-induced migration of lipoproteins. Visualization: Sudan Black lipid-specific stain. Output: visual pattern or densitometric quantification of HDL, VLDL, LDL, and chylomicron fractions.

Indications for Use

Indicated for in vitro diagnostic testing of human plasma or serum to separate and identify lipoprotein subfractions (alpha/HDL, pre-beta/VLDL, beta/LDL, and chylomicrons) via gradient polyacrylamide gel electrophoresis.

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

• Helena Laboratories Titan Gel-Lipoprotein Electrophoresis System (K833611)
• Beckman Instruments Paragon™ Electrophoresis System Lipoprotein Reagent Test Kit (K854057)

Submission Summary (Full Text)

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SEP 3 1996

Zaxis

A new dimension in Technology

K940785

510(k) SUMMARY

LFS Lipogel Assay Kit

February 23, 1996

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87 and the SMDA.

1. Submitter of 510(k)

Company: Zaxis, Inc.
1890 Georgetown Road
Hudson, Ohio 44236

Attn: Kenneth W. Egger
Sales and Marketing Manager

Telephone: [phone]
Fax: [phone]

2. Name of Device:

A. Trade/Proprietary Name:
LFS Lipogel Assay Kit

B. Common/Usual Name:
Electropheretic Gel and Reagents for Lipoprotein Separation

C. Classification Name:
21 CFR 862.1475 "Lipoprotein Test System"

Note: This classification name is in accordance with FDA's publication "Classification Names for Medical Devices and In Vitro Diagnostic Products" (FDA 91-4246). "Lipoproteins Electrophoretic Separation" is cited as the standard product nomenclature in this publication with 21 CFR 862.1475 "Lipoprotein Test System" cited as the corresponding regulation.

1890 Georgetown Rd.
Hudson, OH. 44236
Akron: [phone]
1 Cleve.: [phone]
Fax : [phone]

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3. **Sponsor/Manufacturer:**

Company: Zaxis, Inc.
1890 Georgetown Road
Hudson, Ohio 44236

Attn: Kenneth W. Egger
Sales and Marketing Manager

Telephone: [phone]
Fax: [phone]

4. **Reason for Submitting the 510(k)**

This 510(k) is being submitted for the LFS Lipogel Assay Kit which is a new device. The LFS Lipogel Assay Kit is substantially equivalent to legally marketed predicate devices.

5. **Device Description**

The LFS Lipogel Assay Kit utilizes a gel electrophoresis method for separating lipoproteins. The principle of electrophoresis is based upon the fact that lipoproteins, when placed in an electrical field, will migrate toward one of the electrode poles. The lipids in human plasma are bound to protein and circulate throughout the body as complexes known as lipoproteins. Routine electrophoresis separates lipoprotein complexes into four generally distinct, well-resolved fractions or zones. Each fraction is composed of one or more individual lipoproteins. From the fastest migrating to the slowest, these fractions have been designated as alpha lipoproteins (high density lipoproteins - HDL), pre-beta lipoproteins (very low density lipoproteins - VLDL), beta lipoproteins (low density lipoproteins - LDL), and chylomicrons.

The resulting pattern may be visually interpreted or quantified. After electrophoresis, the lipoproteins in the gel are immobilized in a fixative solution. The lipoprotein pattern is visualized by staining the gel with a lipid-specific stain. With the use of a densitometer, the relative percentage of each lipoprotein fraction can be determined.

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The LFS Lipogel Assay Kit is a complete system containing the reagents, gels, and hardware necessary to perform electrophoretic separation of lipoproteins.

## 6. Intended Use

The LFS Lipogel Assay Kit is indicated for the electrophoretic separation of lipoproteins in a gradient polyacrylamide gel. That is, the LFS Lipogel Assay Kit is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions.

## 7. Substantial Equivalence

The LFS Lipogel Assay Kit has substantially equivalent intended uses and technological characteristics to those of legally marketed predicate devices. The LFS Lipogel Assay Kit, like the predicate devices, is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions. Further, the LFS Lipogel Assay Kit, as well as the predicate devices, are merely laboratory gel electrophoresis systems specifically designed for the separation of lipoproteins. Provided in Table 1 is a comparison of the LFS Lipogel Assay Kit characteristics to that of legally marketed predicate devices.

Table 3-1 Comparison of Technological Characteristics LFS Lipogel Assay Kit and Predicate Devices

| Manufacturer | Zaxis, Inc. | Helena Laboratories | Beckman Instruments |
| --- | --- | --- | --- |
| Device | LFS Lipogel Assay Kit | Titan Gel-Lipoprotein Electrophoresis System | Paragon™ Electrophoresis System Lipoprotein Reagent Test Kit |
| 510k Number | Current 510(k) | K833611 | K854057 |
| Principle of Operation | Electrophoresis | Electrophoresis | Electrophoresis |
| Components | Electronics and Reagents | Electronics and Reagents | Electronics and Reagents |
| Gel | Polyacrylamide | Agarose | Agarose |
| Stain | Sudan Black | Sudan Red | Sudan Black |
| Fractions | VLDL, LDL, HDL | VLDL, LDL, HDL | VLDL, LDL, HDL |

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Performance testing was conducted on the LFS Lipogel Assay Kit to characterize its performance and demonstrate its substantial equivalence to legally marketed predicate devices. The LFS Lipogel Assay Kit was tested for within-run and between-runs reproducibility. The reproducibility of the LFS Lipogel Assay Kit between laboratories was, also, examined. Lastly, the performance of the LFS Lipogel Assay Kit was compared against that of a legally marketed predicate device, the Helena Laboratories' Titan Gel-Lipoprotein Electrophoresis System (K833611). The data demonstrate the substantial equivalence of the LFS Lipogel Assay Kit to legally marketed predicate devices.

In conclusion, the LFS Lipogel Assay Kit, is substantially equivalent to legally marketed predicates.