DIRECT LDL CHOLESTEROL, MODEL L530-60H

K051121 · Teco Diagnostics · MRR · Aug 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051121
• Device Name: DIRECT LDL CHOLESTEROL, MODEL L530-60H
• Applicant: Teco Diagnostics
• Product Code: MRR · Clinical Chemistry
• Decision Date: Aug 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Device Story

Direct LDL Cholesterol assay; homogeneous enzymatic colorimetric method. Input: human serum or plasma samples. Process: two-reagent format; first reagent (alpha-cyclodextrin, dextran sulfate) stabilizes LDL, VLDL, and chylomicrons; second reagent (PEG-modified enzymes) selectively reacts with cholesterol in LDL particles. Output: quantitative LDL-C concentration. Used in clinical laboratories; operated by technicians/clinicians on manual or automated analyzers (e.g., Hitachi 717). Results used by physicians to assess coronary heart disease risk.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics typical of in vitro diagnostic lipoprotein test systems.

Technological Characteristics

In vitro diagnostic reagent system for quantitative LDL-C determination. Operates via chemical reaction in human serum or plasma samples. Class I device, product code MRR (Lipoprotein test system).

Indications for Use

Indicated for quantitative determination of LDL-C in human serum or plasma to identify patients at higher risk for coronary heart disease. For in vitro diagnostic use.

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

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Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jian Vaeches Official FDA Coorespondent TECO Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807

Re: k051121

> Trade/Device Name: Direct LDL Cholesterol Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: July 15, 2005 Received: July 15, 2005

Dear Mr. Vaeches:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## TECO DIAGNOSTICS

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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: [phone] Toll Free: 1-800-222-9880 Fax: [phone] www.tecodiag.com Email:[e-mail]

## Indications for Use

510(k) Number (if known): k051121

Device Name: Direct LDL Cholesterol Reagent

Indications For Use: For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Prescription Use _√

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

K
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K05 1121