HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134

K022053 · Sebia · JHO · Jul 12, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022053
• Device Name: HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
• Applicant: Sebia
• Product Code: JHO · Clinical Chemistry
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Both the qualitative (presence of abnormal or absence of normal fractions) and semi-quantitative (relative increase or decrease of fractions) abnormalities necessitate further lipoprotein analyses. The procedure is indicated for the general population for determination of lipoprotein profiles.

Device Story

In vitro diagnostic test kits for lipoprotein profiling in human serum; utilizes alkaline buffered agarose gel electrophoresis to separate VLDL, LDL, HDL, and chylomicrons. Samples processed via semi-automated HYDRASYS electrophoresis apparatus. Fractions visualized using lipid-specific Sudan black stain. Output consists of electrophoregrams evaluated visually for pattern abnormalities or via densitometry for relative quantification. Used in clinical laboratory settings by trained personnel. Results aid in Fredrickson classification of lipoproteins; qualitative and semi-quantitative findings guide further diagnostic lipoprotein analysis.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance of the electrophoresis assay.

Technological Characteristics

Alkaline buffered agarose gels; lipid-specific Sudan black stain; semi-automated HYDRASYS electrophoresis apparatus; qualitative and semi-quantitative densitometry analysis.

Indications for Use

Indicated for the general population for the determination of lipoprotein profiles in human serum to aid in the interpretation of lipoprotein patterns and Fredrickson classification.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 12 2002

Borek Janik, Ph.D. Offficial Correspondent Morax 13805 Waterloo Chelsea, MI 48118

k022053 Re:

> Trade/Device Name: Hydragel 7 Lipoprotein(E) Hydragel Lipoprotein(E) 15/30 Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: JHO Dated: June 19, 2002 Received: June 24, 2002

Dear Dr. Janik:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement; as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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. .

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact.the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours.

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

(Special 510(k): Device Modif

Device name:

HYDRAGEL 7 LIPOPROTEIN(E) HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4114 PN 4134

## Indications For Use:

The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples.

The assay is carried out in two stages:

· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present.

· visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution.

The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Both the qualitative (presence of abnormal or absence of normal fractions) and semi-quantitative (relative increase or decrease of fractions) abnormalities necessitate further lipoprotein analyses.

The procedure is indicated for the general population for determination of lipoprotein profiles.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Hean Cooper

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(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K022053

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)