DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR

K032936 · Stanbio Laboratory · JIX · Mar 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K032936
• Device Name: DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
• Applicant: Stanbio Laboratory
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

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

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A (within-day CV 0.44-0.56%; day-to-day CV 1.33-1.43%). Linearity confirmed to 520 mg/dL per EP6-P. Method comparison against predicate (N=62) yielded Y=1.025X-4.0289, r=0.9969. Analytical specificity demonstrated against hemoglobin, bilirubin, ascorbic acid, and chylomicrons. No clinical studies performed.

Technological Characteristics

Homogenous enzymatic colorimetric assay. Two-reagent system: R1 contains detergent and phosphoric acid compounds; R2 contains enzymes. Measures absorbance change. Linear range up to 700 mg/dL. In vitro diagnostic use.

Indications for Use

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

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• LDL Cholesterol Plus (k012287)

Submission Summary (Full Text)

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# MAR 1 2 2004

K032936

page 182

## 510(k) SUMMARY

#### Submitter's Name and Address: Phone: [phone] Stanbio Laboratory Fax: [phone] North Main Street e-mail: [e-mail] Boerne, Texas 78006

Prepared By: Adaobi Oguchi September 12, 2003

| Product Name<br>Trade name: | Direct LDL-Cholesterol Liquid Color®; Direct<br>HDL/LDL-Cholesterol Calibrator. |
|-----------------------------|---------------------------------------------------------------------------------|
| Common name: | LDL-Cholesterol; Calibrator |
| Classification name: | Lipoprotein test system; Calibrator. |
| Class: | 1;II |
| Product Code: | MRK<br>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 LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system (Stanbio) is substantially equivalent to LDL Cholesterol Plus (K012287) 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 LDL-Cholesterol.

This is achieved by a homogenous method that directly measures serum LDL-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 HDL, VLDL and chylomicrons leaving the LDL particles exposed.

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## 510(k) SUMMARY CONT'D

K032936

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

#### Indications for use:

Direct LDL Chollesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of lowdensity lipoprotein cholesterol (LDL-C) in serum or plasma. LDL 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 LDL-Cholesterol Liquid Color , calibrated with Direct HDL/LDL -Cholesterol Calibrator (Stanbio) and LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche) using 62 patient samples. A correlation coefficient of 0.9969 and a regression equation of y = 1.025x - 4.0289 was obtained.

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

The result of LDL-cholesterol using Stanbio Direct LDL-Cholesterol Liquid Color is linear to 700mg/dl.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 2 2004

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

Re: k032936

> Trade/Device Name: Stanbio Laboratory Direct LDL 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; MRR 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/clsmamain.html.

Sincerely yours.

Jean M. Cooper, US, 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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510(k) Number (if known): J

K032536

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

### Indications for use:

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

LDL 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) OR Over the Counter Use Prescription Use (Per 21 CFR801.109)

Carol Benson
Division Sign

510(K) K032936

(Optional Format 1-2-96)