LFS LIPOGEL ASSAY KIT

• K Number: K960785
• Device Name: LFS LIPOGEL ASSAY KIT
• Manufacturer: ZAXIS, INC.
• Date Cleared: 1996-09-03 ( 190 days)
• Product Code: JHO
• Regulation Number: 862.1475

Intended Use

The Assay Kit is indicated LFS Lipogel 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 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. lach fraction is composed of one or more individual lipoproteins. From the fastest migrating to the slowest, these fractions have been b designated alpha a 2 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 qel lipid-specific stain. with a With the use of densitometer, the relative percentage of each lipoprotein fraction can be determined. The LFS Lipogel Assay Kit is a complete system containing the reagents, gels, and hardware necessary to perform electrophoretic separation of lipoproteins.

Predicate Devices

K833611, K854057

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a traditional gel electrophoresis method and densitometry for analysis, with no mention of AI or ML.

Therapeutic

No
The device is described as an "in vitro diagnostic device intended to test human plasma or serum," indicating it is used for diagnostic purposes, not for treating a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "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."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the LFS Lipogel Assay Kit is a complete system containing reagents, gels, and hardware necessary to perform the electrophoretic separation. This indicates it is a hardware-based device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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." This directly identifies the device as an in vitro diagnostic.
• Device Description: The description details a method for analyzing components (lipoproteins) within a human sample (plasma or serum) using a laboratory technique (gel electrophoresis). This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Assay Kit is indicated LFS Lipogel 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.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

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. lach fraction is composed of one or more individual lipoproteins. From the fastest migrating to the slowest, these fractions have been b designated alpha a 2 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 qel lipid-specific stain. with a With the use of densitometer, the relative percentage of each lipoprotein fraction can be determined.

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

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

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K833611, K854057

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

SEP 3 1996

Image /page/0/Picture/1 description: The image shows the word "Zaxis" in a stylized font, with a horizontal line underlining the word. Below the word "Zaxis" is the phrase "A new dimension in Technology". The text is in black and the background is white.

K940785

510 (k) SUMMARY LFS Lipogel Assay KI t 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:
     Trade/Proprietary Name: A.

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 requlation.

1890 Georgetown Rd. Hudson, OH. 44236

Akron: [phone] 1 Cleve .: [phone] Fax : [phone]

1

• Sponsor/Manufacturer: 3.
  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. lach fraction is composed of one or more individual lipoproteins. From the fastest migrating to the slowest, these fractions have been b designated alpha a 2 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 qel lipid-specific stain. with a With the use of densitometer, the relative percentage of each lipoprotein fraction can be determined.

87

2

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 Assay Kit is indicated LFS Lipogel 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 Kit, like the predicate devices, is an in vitro Assay 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

3

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.