DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR

K032932 · Stanbio Laboratory · LBS · Mar 10, 2004 · Clinical Chemistry

Device Facts

• Record ID: K032932
• Device Name: DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
• Applicant: Stanbio Laboratory
• Product Code: LBS · Clinical Chemistry
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic Use Only.

Device Story

System uses two-reagent homogenous method to measure serum/plasma HDL-C directly without pretreatment or centrifugation. Reagent 1 (detergent, phosphoric acid compounds) binds LDL, VLDL, and chylomicrons, exposing HDL particles. Reagent 2 (enzymes) reacts with exposed HDL-cholesterol. Used in clinical laboratory settings by trained personnel. Output is quantitative HDL-C concentration. Results assist clinicians in diagnosing and managing lipid/lipoprotein metabolism disorders.

Clinical Evidence

Bench testing only. Method comparison study performed using 50 patient samples against predicate device (K000568). Results showed correlation coefficient of 0.9987 and regression equation y = 1.01x - 0.4942. Linearity established up to 200 mg/dL. Analytical sensitivity reported as 0.001 absorbance units per 0.4 mg/dL HDL-C. Precision and interference studies met acceptable ranges.

Technological Characteristics

Homogenous enzymatic colorimetric assay. Two-reagent system: R1 contains detergents and phosphoric acid compounds; R2 contains enzymes. Measures HDL-C directly in serum/plasma. Linear range up to 200 mg/dL. Analytical sensitivity 0.4 mg/dL per 0.001 absorbance units.

Indications for Use

Indicated for the quantitative determination of HDL-C in serum or plasma to aid in the diagnosis and treatment of lipid and lipoprotein metabolism disorders in patients.

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.

Predicate Devices

• HDL Cholesterol Plus (K000568)

Submission Summary (Full Text)

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MAR 1 0 2004

## 510(k) SUMMARY

1032932

| Submitter's Name and Address: |
|-------------------------------|
|-------------------------------|

| Stanbio Laboratory. | Phone: [phone] |
|------------------------|-----------------------------|
| 1261 North Main Street | Fax: [phone] |
| Boerne, Texas 78006 | e-mail: [e-mail] |

| Prepared By: | Adaobi Oguchi |
|--------------|--------------------|
| | September 12, 2003 |

| Product Name | |
|----------------------|----------------------------------------------------------------------------------|
| Trade name: | Direct HDL-Cholesterol Liquid Color® ; Direct<br>HDL/LDL-Cholesterol Calibrator. |
| Common name: | Lipoprotein test system; Calibrator |
| Classification name: | LDL & VLDL precipitation, cholesterol via Esterase-<br>Oxidase, HDL; Calibrator. |
| Class: | I;II |
| Product Code: | LBS; JIX |
| Manufacture: | Stanbio Laboratory,<br>1261 North Main Street<br>Boerne, Texas 78006 |

The establishment Registration No. is 1616487.

Substantial Equivalence of Device

The Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system (Stanbio) is substantially equivalent to HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).

Description of Device

The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol.

This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps.

It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed.

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## 510(k) SUMMARY CONT'D

K032932
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The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.

Indications for use:

Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

### Performance Data

Substantial equivalency was demonstrated by method comparison. Correlation study was performed between Direct HDL-Cholesterol Liquid Color®, calibrated with Direct HDL/LDL -Cholesterol Calibrator (Stanbio ) and HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche) using 50 patient samples. A correlation coefficient of 0.9987 and a regression equation of y = 1.01x -0.4942 was obtained.

Also, precision, linearity, sensitivity and interference studies were performed on Stanbio Direct HDL-Cholesterol Liquid Color . Results of these tests were within acceptable range.

The result of HDL-cholesterol using Stanbio Direct HDL-Cholesterol Liquid Color is linear to 200mg/dl.

For the analytical sensitivity, a change of 0.001 absorbance units is equivalent to approximately 0.4mg/dl of HDL Cholesterol.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 0 2004

Ms. Adaobi Oguchi Ouality Control Manager Stanbio Laboratory 1261 North Main Street Boerne, TX 78006

k032932 Re:

Trade/Device Name: Stanbio Laboratory Direct HDL Cholesterol LiquiColor® and Stanbio Direct HDL/LDL Cholesterol Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX; LBS Dated: December 18, 2003 Received: December 22, 2003

Dear Ms. Oguchi:

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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper MS, DVM.

Yean M. Cooper, MS, D.V.M. 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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X232932 510(k) Number (if known): ____________________

Stanbio Laboratory Direct HDL Cholesterol LiquiColor® and Stanbio Direct Device Name: HDL/LDL Cholesterol Calibrator

Indications for use:

Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma.

HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

. *

For In Vitro Diagnostic Use Only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR801.109)

OR

Over the Counter Use

Carol Benson

ivision Slan-O

Office of In Vitro Diagn Device Evaluation and

510(k) K032932