LDL CHOLESTEROL (AUTOMATED)

K022519 · Jas Diagnostics, Inc. · JHM · Sep 30, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022519
• Device Name: LDL CHOLESTEROL (AUTOMATED)
• Applicant: Jas Diagnostics, Inc.
• Product Code: JHM · Clinical Chemistry
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

Device Story

The LDL Cholesterol (Automated) Reagent is an in vitro diagnostic reagent used for the quantitative measurement of LDL cholesterol in human serum. It is designed for use on automated chemistry analyzers in clinical laboratory settings. The reagent facilitates the biochemical determination of LDL levels, which healthcare providers use to assess patient risk for coronary heart disease and coronary artery disease. By providing accurate LDL measurements, the device assists clinicians in diagnosing lipid disorders and monitoring the efficacy of treatment plans, ultimately helping to manage cardiovascular health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics typical of in vitro diagnostic reagents for lipid testing.

Technological Characteristics

In vitro diagnostic reagent for automated chemistry analyzers. Quantitative biochemical assay for LDL cholesterol in human serum.

Indications for Use

Indicated for the in vitro, quantitative determination of LDL cholesterol in human serum to aid in the diagnosis and treatment of disorders involving high LDL cholesterol, which is associated with increased risk of coronary heart disease and coronary artery disease.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 098 Gaither Road Rockville MD 20850

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

Re:

SEP 3 0 2002

k022519 Trade/Device Name: LDL Cholesterol (Automated) Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR; JHM; JIX; JJY Dated: July 19, 2002 Received: July 30, 2002

Dear Mr. Johnston:

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 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 [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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510(k) Number (if known): Device Name: LDL Cholesterol (Automated) REAGENT Indications for Use:

Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers.

LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cohen

Prescription Use I (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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