VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

K012593 · Ortho-Clinical Diagnostics, Inc. · LBR · Aug 30, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012593
• Device Name: VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LBR · Clinical Chemistry
• Decision Date: Aug 30, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. VITROS Calibrator Kit 2 For in vitro diagnostic use only. VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.

Device Story

Device consists of Magnetic HDL-Cholesterol Reagent, VITROS CHOL slides, and Calibrator Kit 2. Used on VITROS 250, 550, 750, and 950 Series Analyzers. Principle: HDL separated by precipitation of LDL/VLDL using dextran sulfate and magnesium chloride; polymer-coated iron particles enhance precipitation; magnetic field removes non-HDL lipoproteins. Remaining HDL cholesterol measured via dry, multilayered slide using reflectance spectrophotometry. Operated by laboratory personnel in clinical settings. Output provides quantitative HDL-cholesterol concentration, aiding clinicians in assessing coronary heart disease risk.

Clinical Evidence

Bench testing only. Performance was validated using patient and quality control samples spanning the assay range (3.0-100.0 mg/dL) to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Dry, multilayered slide technology; reflectance spectrophotometry. Reagents include dextran sulfate (50,000 MW), magnesium chloride, and polymer-coated magnetic particles. Instrumentation: VITROS 250, 550, 750, 950 Series Analyzers. Incubation: 5 minutes at 37°C.

Indications for Use

Indicated for the quantitative measurement of HDL-cholesterol in human serum and plasma to evaluate the risk of coronary heart disease (CHD).

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

• VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (K984303)

Submission Summary (Full Text)

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## Summary Information

#### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 012593

- Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact [phone]
Marlene A. Shulman Contact Person:

- Date Special 510(k) prepared: August 9, 2001 2. Preparation date
- 3. Device Trade or Proprietary Name: VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent name VITROS CHOL Slide VITROS Chemistry Products Calibrator Kit 2 Common Name: HDLC Precipitating Reagent Classification Name: LDL & VLDL Precipitation, HDL
- The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and 4. Predicate VITROS CHOL Slides (modified) and VITROS Chemistry Products device Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.

Continued on next page

3

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#### 510(k) Summary, Continued

- The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and 7. Comparison VITROS CHOL Slides (modified) and VITROS Chemistry Products to Predicate VITROS CHOE Shaos (instally equivalent to VITROS Chemistry Products Device Canorator Rit 2 are Sabbaniano, expent and VITROS CHOL Slides for use with Magnetic HDL-Cholesteror Reagues cleared by the FDA (K984303 January 28, 1999) for in vitro diagnostic use.
Table 1 lists the characteristics of the tests performed using the VITROS Fable I hists the entarasterol Reagent and VITROS CHOL Slide (current) and Magnetic HDL Cholesterol Reagent and VITROS CHOL Slides (modified)

| Table I List of Device Characteristics. Comparison to | | | |
|--------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------|--|
| Device | Predicate Device | New Device | |
| Characteristic | VITROS Magnetic HDL-Cholesterol | VITROS Magnetic HDL-Cholesterol | |
| | Reagent and VITROS CHOL Slide | Reagent and VITROS CHOL Slide | |
| | (Current) | (Modified) | |
| Sample volume | 10 uL | 5.5 µL | |
| Quantity of | Triton X-100 0.91 mg; cholesterol oxidase | Triton X-100 0.73 mg; cholesterol oxidase | |
| Reactive | (Nocardia or Cellulomonas, E.C.1.1.3.6) 0.45 U; | (Nocardia or Cellulomonas, E.C.1.1.3.6) 0.36 U; | |
| Ingredients per | cholesterol ester hydrolase (Candida rugosa or | cholesterol ester hydrolase (Candida rugosa or | |
| CHOL slide (test) | Pseudomonas, E.C.3.1.1.13) 2.25 U; peroxidase | Pseudomonas, E.C.3.1.1.13) 1.80 U; peroxidase | |
| | (horseradish root, E.C.1.11.1.7) 5.85 U; and 2- | (horseradish root, E.C.1.11.1.7) 4.68 U; and 2- | |
| | (3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4- | (3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4- | |
| | dimethylaminophenyl) imidazole (leuco dye) 0.25 | dimethylaminophenyl) imidazole (leuco dye) 0.13 | |
| | mg. | mg. | |
| Intended Use | For in vitro diagnostic use only. | No Change. | |
| | The VITROS Magnetic HDL reagent and | | |
| | VITROS Cholesterol slides quantitatively measure | | |
| | HDL-cholesterol (HDLC) in serum and plasma. | | |
| Concentrations of | Triton X-100 0.81 mg; cholesterol oxidase | No Change. | |
| CHOL Reactive | (Nocardia or Cellulomonas, E.C.1.1.3.6) 0.4 U; | | |
| Ingredients per | cholesterol ester hydrolase (Candida rugosa or | | |
| cm-squared | Pseudomonas, E.C.3.1.1.13) 2.0 U; peroxidase | | |
| | (horseradish root, E.C.1.11.1.7) 5.2 U; and 2-(3,5- | | |
| | dimethoxy-4-hydroxyphenyl)-4,5-bis(4- | | |
| | dimethylaminophenyl) imidazole (leuco dye) 0.17 | | |
| | mg. | | |
| Magnetic HDL- | Dextran sulfate (50,000 MW); Magnesium | No Change. | |
| Cholesterol | Chloride, Magnetically responsive particles. | | |
| Reagent Reactive | | | |
| Ingredients. | | | |

#### vice Characteristics: Comparison to Predicate Device

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## 510(k) Summary, Continued

| Device<br>Characteristic | Predicate Device<br>VITROS Magnetic HDL-Cholesterol<br>Reagent and VITROS CHOL Slide<br>(Current) | New Device<br>VITROS Magnetic HDL-Cholesterol<br>Reagent and VITROS CHOL Slide<br>(Modified) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Basic principle | HDL is separated by precipitation of LDL and<br>VLDL by using dextran sulfate (MW 50,000) and<br>magnesium chloride. The reagent also contains<br>iron particles that are coated with a polymer. The<br>polymer enhances the precipitation of the non-<br>HDL lipoproteins onto the iron particles. The<br>precipitated non-HDL lipoproteins are removed<br>from the supernate by applying a magnetic field.<br>Following pretreatment of the sample, HDL<br>cholesterol is measured by a dry, multilayered<br>slide utilizing reflectance spectrophotometry | No Change. |
| Sample type | Serum , plasma | No Change. |
| Assay Range<br>Serum, Plasma | 3.0- 100.0 mg/dL | No Change. |
| Instrumentation | VITROS 250, 550, 750 and 950 Series Analyzers | No Change. |
| Incubation time<br>and temperature | 5 minutes at 37°C | No Change. |

#### 8. Conclusions

The information presented in this pre-market notification demonstrates that The information probential with on of the VITROS HDL-Cholesterol Reagent and CHOL the performance or ar use with human serum and plasma is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range.

The information presented in this premarket notification provide a reasonable The miorination prosition Magnetic HDL-Cholesterol Reagent and CHOL assuration that the for use with human serum and plasma is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers of the bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 3 0 2001

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

K012593 Re:

K012393
Trade/Device Name: VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent, VITROS CHOL Slide, and VITROS Chemistry Products Calibrator Kit 2

Regulation Number: 21 CFR 862.1150

Regulatory Class: II Product Code: JIS Regulation Number: 21 CFR 862.1475 Regulatory Class: I, reserved Product Code: LBR Dated: August 9, 2001 Received: August 10, 2001

Dear Mr. Shulman:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your boourer b r (=) ce (= ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Americans, or to devices and into t (Act). You may, therefore, market the device, subject to I coord i ood, Drug, and Goodions of the Act. The general controls provisions of the Act include the general controls pro About of usting 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 Children Approval), it the Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your determination assumes compliance with the Good Manufacturing A Substantally equivalent avoilable (GMP) regulation (21 CFR Part 820) and that, through I ractive for Mourcal toos, the Food and Drug Administration (FDA) will verify such perfour offirms, Failure to comply with the GMP regulation may result in regulatory action. In assumptions: That are to centry ther announcements concerning your device in the Federal adultion, I Dri may paches response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the ally Controll Journageation Control provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your distantial equivalence of your device to a legally marketed nouthoute 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 11 you desire books an in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. I radiation f 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 monfacturers 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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# Statement of Intended Use

Page 1 of 1

| 510(k) Number (if known): | K012593 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products Magnetic HDL-Cholesterol<br>Reagent<br>VITROS CHOL Slide<br>VITROS Chemistry Products Calibrator Kit 2 |
| Intended Use: | For in vitro diagnostic use only.<br>The VITROS Magnetic HDL-Cholesterol Reagent and VITROS<br>CHOL Slides quantitatively measure HDL cholesterol (HDLC)<br>concentration in serum and plasma. |
| | VITROS Calibrator Kit 2 |
| | For in vitro diagnostic use only.<br>VITROS Calibrator Kit 2 is intended for use in calibration of the<br>VITROS Chemistry Systems for the quantitative measurement<br>of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG. |
| Summary and Explanation of<br>Test: | HDL cholesterol is used to evaluate the risk of developing<br>coronary heart disease (CHD). The risk of CHD increases with<br>lower HDL cholesterol concentrations. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use __

Keria Alexander for Joan Cooper
(Division Sign-Off)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012593