VITROS CHEMISTRY PRODUCTS DHDL SLIDES

K120609 · Ortho-Clinical Diagnostics, Inc. · LBS · Sep 7, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120609
• Device Name: VITROS CHEMISTRY PRODUCTS DHDL SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.

Device Story

VITROS Chemistry Products dHDL Slides; in vitro diagnostic device for quantitative HDL-C measurement in serum/plasma. Modification involves reduced slide surface area and proportional reduction in reagent amounts per test; reduced sample volume requirement. Operates on VITROS Chemistry Systems; used in clinical laboratory settings by trained personnel. Output provides HDL-C concentration values to assist clinicians in lipid profile assessment and cardiovascular risk evaluation. Modification maintains fundamental scientific technology of predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing demonstrating that the modified slide performs equivalently to the predicate despite the reduction in sample volume and slide surface area.

Technological Characteristics

In vitro diagnostic slide-based assay; colorimetric/enzymatic detection principle. Modification: reduced slide surface area and proportional reagent volume adjustment. Compatible with VITROS Chemistry Systems.

Indications for Use

Indicated for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma.

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 Chemistry Products dHDL Slides (k042006)

Submission Summary (Full Text)

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K120609

SEP 7 2012

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## Special 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR
807.92.

| Submitter Information | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Ortho Clinical Diagnostics | |
| Address | 100 Indigo Creek Drive, Rochester, NY 14626, USA | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment<br>Registration Number | 1319809 | |
| Name of contact<br>person | Marlene A. Hanna | |
| Date prepared | February 24, 2012 | |
| Name of device | | |
| Trade or proprietary<br>name | VITROS Chemistry Products dHDL Slide | |
| Common or usual<br>name | HDL Cholesterol assay | |
| Classification name | Lipoprotein test system | |
| Classification panel | Clinical Chemistry | |
| Regulation | 21 CFR 862.1475 | |
| Product Code(s) | LBS | |
| Legally marketed device(s)<br>to which equivalence is<br>claimed | The VITROS Chemistry Products dHDL Slide (modified) are substantially<br>equivalent to the VITROS Chemistry Products dHDL Slides (current slide).<br>The FDA cleared the VITROS Chemistry Products dHDL Slides on October<br>26, 2004 (k042006). | |
| Reason for 510(k)<br>submission | A Special 510(k) for a modification to own device which does not include a change<br>in intended use or fundamental technology. Each modified VITROS dHDL Slide will<br>have 30% less ingredients compared to the current VITROS dHDL Slide as a result<br>of a smaller surface area. Since the reduction in ingredients per slide is due to a<br>smaller surface area, the concentration of ingredients of the modified slide will be<br>unchanged compared to the current slide. The device modification results in a<br>reduction in the sample volume required per test from 10 µL per test to 6 µL per test. | |
| Device description | The VITROS dHDL assay is performed using the VITROS Chemistry Products<br>dHDL Slide and the VITROS Chemistry Products Calibrator Kit 25 on the VITROS<br>Chemistry Systems. The VITROS dHDL Slide is a multi-layered analytical element<br>coated on a polyester support. The method is based on a non-HDL precipitation<br>method followed by an enzymatic detection. All reactions necessary for a single<br>quantitative measurement of HDLC take place within the multi-layered analytical<br>element of a VITROS Chemistry Products dHDL Slide. A drop of sample fluid is<br>metered onto the slide and a reaction occurs which ultimately generates a colored<br>dye. The density of dye formed is proportional to the HDL Cholesterol concentration<br>present in the sample and is measured by reflectance spectrophotometry. | |
| Intended use of the device | For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products dHDL Slides are used<br>to quantitatively measure HDL cholesterol (HDLC) concentration in serum and<br>plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the<br>VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is<br>used to evaluate the risk of developing coronary heart disease (CHD). The risk of<br>CHD increases with lower HDL cholesterol concentrations. | |
| Indications for use | High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing<br>coronary heart disease (CHD). The risk of CHD increases with lower HDL<br>cholesterol concentrations. | |
| Summary of the technological characteristics of the device compared to the predicate device | | |
| Characteristic | New Device[ Modified VITROS dHDL<br>Slide] | Predicate [VITROS dHDL Slide]<br>[k042006] |
| Intended Use | Same | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products<br>dHDL Slides are used to<br>quantitatively measure HDL<br>cholesterol (HDLC) concentration<br>in serum and plasma using<br>VITROS 250/350/950 and 5,1 FS<br>and 4600 Chemistry Systems and<br>the VITROS 5600 Integrated<br>System. High Density Lipoprotein<br>(HDL) cholesterol is used to<br>evaluate the risk of developing<br>coronary heart disease (CHD).<br>The risk of CHD increases with<br>lower HDL cholesterol<br>concentrations. |
| Fundamental technology | Same | Dry, multilayered slide utilizing<br>method based on a non-HDL<br>precipitation method followed by<br>enzymatic detection, measured<br>by reflectance spectrophotometry. |
| Sample Volume Required | 6 μL | 10 μL |
| Instrumentation | Same | VITROS 250/350/950 and 5,1 FS<br>and 4600 Chemistry Systems and<br>the VITROS 5600 Integrated<br>System. |
| Concentration of dHDL<br>Slide Reactive Ingredients<br>per Slide (test) | Same | Emulgen B-66 0.7 mg;<br>phosphotungstic acid 0.3 mg;<br>magnesium chloride 0.2 mg,<br>cholesterol oxidase<br>(Cellulomonas, E.C.1.1.3.6) 0.8 U;<br>cholesterol ester hydrolase<br>(Candida rugosa, E.C.3.1.1.3) 1.2<br>U; peroxidase (horseradish root,<br>E.C.1.11.1.7) 2.2 U; and 2-(3,5-<br>dimethoxy-4-hydroxyphenyl)-4,5-<br>bis-(4-dimethylaminophenyl)<br>imidazole (leuco dye) 0.02 mg |
| Amount of dHDL Slide ·<br>Reactive Ingredients per<br>Slide (test) | Emulgen B-66 0.63 mg; phosphotungstic<br>acid 0.27 mg; magnesium chloride 0.15<br>mg, cholesterol oxidase (Cellulomonas,<br>E.C.1.1.3.6) 0.72 U; cholesterol ester<br>hydrolase (Candida rugosa, E.C.3.1.1.3)<br>1.10 U; peroxidase (horseradish root,<br>E.C.1.11.1.7) 2.0 U; and 2- (3,5-<br>dimethoxy-4-hydroxyphenyl)-4,5-bis-(4-<br>dimethylaminophenyl) imidazole (leuco<br>dye) 0.018 mg. | Emulgen B-66 0.90 mg;<br>phosphotungstic acid 0.38 mg;<br>magnesium chloride 0.22 mg,<br>cholesterol oxidase<br>(Cellulomonas, E.C.1.1.3.6) 1.0 U;<br>cholesterol ester hydrolase<br>(Candida rugosa, E.C.3.1:1.3)<br>1.56 U; peroxidase (horseradish<br>root, E.C.1.11.1.7) 2.82 U; and 2-<br>(3,5-dimethoxy-4-hydroxyphenyl)-<br>4,5-bis-(4-dimethylaminophenyl)<br>imidazole (leuco dye) 0.026 mg |
| Sample Type | Same | Serum, plasma |
| Measuring Range | Same | 5.0 - 110.0 mg/dL |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | |
| The information presented in the premarket notification provides a reasonable assurance that the VITROS<br>Chemistry Products dHDL Slides (modified) for use with human serum and plasma is substantially equivalent<br>to the predicate (unmodified VITROS dHDL Slide) and is safe and effective for the stated intended use. | | |

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). 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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 26, 2012

Ortho-Clinical Diagnostics, Inc. c/o Marlene Hanna 100 Indigo Creek Drive Rochester, NY 14626-5101

> k120609 Trade Name: VITROS Chemistry Products dHDL Slides Regulation Number: 21 CFR §862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I, meets limitations of exemption 862.9 (c)(4) Product Codes: LBS Dated: August 9, 2012 Received: August 10, 2012

Dear Ms. Hanna:

Re:

This letter corrects our substantially equivalent letter of September 7, 2012.

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Marlene Hanna

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carol C. Benson

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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## Indication for Use

510(k) Number (if known): 长 \ 2 こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ こ 。

Device Name: VITROS Chemistry Products dHDL Slides

Indication For Use: For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5, I FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

R. t. Chisholm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120609

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