HYDRAGEL 7,15,30, CHOL-HDL KIT

K972015 · Morax · LBT · Oct 27, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972015
• Device Name: HYDRAGEL 7,15,30, CHOL-HDL KIT
• Applicant: Morax
• Product Code: LBT · Clinical Chemistry
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the lipoproteins in human plasma or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions if the sample's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.

Device Story

Device uses electrophoresis on alkaline buffered agarose gels to separate lipoproteins (VLDL, LDL, HDL, chylomicrons, Lp(a)) in human plasma or serum samples. Visualization achieved via cholesterol-specific enzymatic reaction (cholesterol esterase, cholesterol oxidase, chromogenic system with reduced AEC and peroxidase). HYDRAGEL CHOL-HDL kit uses manual electrophoresis apparatus (up to 8 samples/gel); HYDRAGEL 7, 15, 30 CHOL-HDL kits use semi-automated Hydrasys apparatus (7, 15, 30 samples/gel respectively). Output consists of stained electrophoregrams interpreted visually for identification and via densitometry for relative cholesterol concentration quantification. Healthcare providers use densitometric data to calculate cholesterol distribution in g/L or mol/L if total cholesterol is known. Assists in lipid profile assessment and HDL cholesterol monitoring.

Clinical Evidence

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

Technological Characteristics

Alkaline buffered (pH 9.4) agarose gels; cholesterol-specific enzymatic visualization (cholesterol esterase, cholesterol oxidase, AEC/peroxidase chromogenic system); manual or semi-automated electrophoresis apparatus; densitometry-based quantification.

Indications for Use

Indicated for the quantification of cholesterol carried by lipoproteins in human plasma or serum. Used in clinical laboratory settings for the separation and measurement of VLDL, LDL, HDL, chylomicrons, and Lp(a) fractions.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 27 1997

Dr. Borek Janik Official Correspondent Morax, Inc. 13805 Waterloo 48118 Chelsea, Michagan

K972015 Re : HYDRAGEL CHOL-HDL Kit and HYDRAGEL7, 15, & 30 CHOL-HDL Kits Requlatory Class: I Product Code: LBT Dated: September 17, 1997 Received: September 22, 1997

Dear Dr Janik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA~88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

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):

Device name:

HYDRAGEL CHOL-HDL KIT HYDRAGEL 7 CHOL-HDL KIT HYDRAGEL 15 CHOL-HDL KIT HYDRAGEL 30 CHOL-HDL KIT

## Indications For Use:

HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a of alkaline banered (p).
cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain viccurale, relative concentrations of cholesterol in the individual lipoprotein fractions if the somole's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.

All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out in two stages:

· electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present,

· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase.

The HYDRAGEL CHOL-HDL kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel.

The HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL 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.

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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k972015

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)_