MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

K012789 · Morax · JHO · Jan 17, 2002 · Clinical Chemistry

Device Facts

• Record ID: K012789
• Device Name: MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
• Applicant: Morax
• Product Code: JHO · Clinical Chemistry
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages: · electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons, · visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen. The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated. The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders. The procedure is indicated for the general population for a direct measurement of: - . the LDL cholestero! level regardless the triglyceride levels - the HDL cholesterol level . - the ratio LDL/HDL cholesterol . The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 samples per gel. The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

Device Story

In vitro diagnostic test system for quantification of cholesterol in LDL and HDL fractions of human serum; utilizes agarose gel electrophoresis to separate VLDL, LDL, HDL, and chylomicrons; employs enzymatic visualization using cholesterol esterase/cholesterol dehydrogenase system with nitro blue tetrazolium chromogen; output consists of stained electrophoregrams for visual interpretation and densitometry to determine relative cholesterol concentrations; used in clinical laboratory settings by trained personnel; results aid physicians in diagnosing and treating lipid disorders; enables direct LDL measurement regardless of triglyceride levels.

Clinical Evidence

No clinical data provided; device relies on bench testing and established enzymatic/electrophoretic principles for lipoprotein quantification.

Technological Characteristics

Agarose gel electrophoresis system; enzymatic visualization using cholesterol esterase/cholesterol dehydrogenase and nitro blue tetrazolium chromogen; manual (K20) or semi-automated (Hydrasys) apparatus; in vitro diagnostic use.

Indications for Use

Indicated for the general population for the direct measurement of LDL cholesterol, HDL cholesterol, and the LDL/HDL cholesterol ratio in human serum as an aid in the diagnosis and treatment of lipid disorders.

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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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 resembling three stylized stripes or chevrons, which are meant to represent the human services aspect of the department.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 7 2002

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

k012789 Re:

Trade/Device Name: HYDRAGEL LDL/HDL CHOL Direct K20 PN 3005 HYDRAGEL 7 LDL/HDL CHOL Direct PN 4109 HYDRAGEL LDL/HDL CHOL Direct 15/30 PN 4129

Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: JHO Dated: December 21, 2001 Received: December 27, 2001

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, listing 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 requirements 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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Page 2 -

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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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K012789

## 510(k) Number (if known): Special 510(k): Device Modification

| Device name: | HYDRAGEL LDL/HDL CHOL Direct K20 | PN 3005 |
|--------------|------------------------------------|---------|
| | HYDRAGEL 7 LDL/HDL CHOL Direct | PN 4109 |
| | HYDRAGEL LDL/HDL CHOL Direct 15/30 | PN 4129 |

## Indications For Use:

HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:

· electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons,

· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen.

The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated.

The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.

The procedure is indicated for the general population for a direct measurement of:

- . the LDL cholestero! level regardless the triglyceride levels
- the HDL cholesterol level .
- the ratio LDL/HDL cholesterol .

The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 samples per gel.

The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Clinical Laboratory De | |
| 510(k) Number | K012789 |

| Prescription Use (Per 21 CFR 801,109) | OR | Over-The Counter Use ______ |
|---------------------------------------|----|-----------------------------|
|---------------------------------------|----|-----------------------------|

(Optional Format 1-2-96)