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

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 Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a detailed validation document.

The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, but it does not typically involve the rigorous clinical study details you're asking for.

Therefore, I cannot provide the requested information from this document. The document refers to the device's "indications for use" and states that "The analysis is performed in two stages," but does not provide performance metrics, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications.

The information you are requesting would usually be found in the 510(k) submission itself (which is not fully provided here) or in a separate validation report prepared by the manufacturer.

Summary

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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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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

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.

(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 ______
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(Optional Format 1-2-96)

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.