DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

K050823 · Teco Diagnostics · LBR · Jul 26, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050823
• Device Name: DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
• Applicant: Teco Diagnostics
• Product Code: LBR · Clinical Chemistry
• Decision Date: Jul 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

Teco Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. This reagent set is intended for in vitro diagnostic use only.

Device Story

The Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator are in vitro diagnostic reagents used for the quantitative measurement of HDL-C in human serum or plasma samples. The device is used in clinical laboratory settings by trained laboratory personnel. The reagent facilitates the biochemical determination of HDL-C levels, which healthcare providers use to assess a patient's risk for coronary heart disease. By providing accurate cholesterol quantification, the device aids in clinical decision-making regarding cardiovascular health management and risk stratification.

Clinical Evidence

No clinical data provided; the submission relies on bench testing and performance validation typical for in vitro diagnostic reagent kits.

Technological Characteristics

In vitro diagnostic reagent set for biochemical analysis of serum or plasma. Utilizes chemical reagents for HDL-C quantification. Standard laboratory diagnostic format.

Indications for Use

Indicated for the quantitative determination of HDL-C in human serum or plasma to assist in identifying patients at higher risk for coronary heart disease. Low HDL-C levels are associated with increased risk. 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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has its head turned to the left.

JUL 26 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jian Vaeches Official FDA Correspondent TECO Diagnostics 1268 N. Lakeview Avenue Anaheim CA 92807

k050823 Re:

K050623
Trade/Device Name: Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS, LBR Dated: July 15, 2005 Received: July 15, 2005

Dear Ms. Vaeches:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 70 ttg 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 r ou may a 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 r rease be actised 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).

{1}------------------------------------------------

## Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anon you to bogin twating of substantial equivalence of your device to a legally premarket notification. "The PDs 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, If you destre specific infortion and advertising of your device, please contact the Office of In of questions on the promountion and Safety at [phone]. Also, please note the VINO Dugliostic Device Dradian by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outline of Senall 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

{2}------------------------------------------------

## TECO DIAGNOSTICS

Image /page/2/Picture/1 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The overall design is simple and graphic, suggesting a logo or symbol.

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):__Unknown at this time K 0 323

Device Name: Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator

Indications For Use: Teco Direct HDLADL Calibration of Teco Diagnostics' Direct HDL and In aroutlorio For DOC Yood Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the Direct LDC onvestern Reagent oo in Solan Ui pprotein cholesterol (HDL-C) in human serum or plasma. HDL quantialive decemination of mgn dontiny in dentifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Prescription Use V

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)


Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safet

510(k) k050823