VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

K152433 · Ortho Clinical Diagnostics · DCK · Sep 24, 2015 · Immunology

Device Facts

• Record ID: K152433
• Device Name: VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
• Applicant: Ortho Clinical Diagnostics
• Product Code: DCK · Immunology
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

VITROS Chemistry Products CRP Slides: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections. VITROS Chemistry Products Calibrator Kit 7: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.

Device Story

VITROS Chemistry Products CRP Slides; in vitro diagnostic assay for quantitative CRP measurement in human serum/plasma; utilizes thin-film multilayer slide technology; operated by laboratory personnel in clinical settings; modification involves updating calibrator reference standard from ERM-DA472 to ERM-DA474; output provides CRP concentration values to aid clinical inflammation assessment.

Clinical Evidence

Bench testing only. Performance studies conducted to verify the impact of the calibrator reference standard change (ERM-DA472 to ERM-DA474) on assay performance. No clinical data provided.

Technological Characteristics

Thin-film multilayer slide technology for quantitative chemistry analysis. Modification: update of calibrator reference standard to ERM-DA474. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma to aid in the evaluation of inflammation.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• VITROS Chemistry Products CRP Slides and VITROS Chemistry Products Calibrator Kit 7 (K030626)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's symbol, which is a stylized image of three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ORTHO-CLINICAL DIAGNOSTICS, INC. MS. JESSICA MILLER SENIOR REGULATORY AFFAIRS ASSOCIATE 100 INDIGO CREEK DRIVE ROCHESTER, NEW YORK 14626

Re: K152433

Trade/Device Name: VITROS Chemistry Products CRP Slides VITROS Chemistry Products Calibrator Kit 7 Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein immunological test system Regulatory Class: II Product Code: DCK, JIT Dated: August 26, 2015 Received: August 27, 2015

Dear Ms. Miller:

September 24, 2015

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 vour 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

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807): labeling (21 CFR Parts 801 and 809); medical device reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

# Kelly Oliner -S

FOR

Leonthena Carrington, MS, MBA, MT (ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K152433

Device Name

VITROS Chemistry Products CRP Slides and VITROS Chemistry Products Calibrator Kit 7

Indications for Use (Describe)

VITROS Chemistry Products CRP Slides:

For in vitro diagnostic use only.

VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections.

VITROS Chemistry Products Calibrator Kit 7:

For in vitro diagnostic use only.

VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary VITROS Chemistry Products CRP Slides, Calibrator Kit 7

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, Inc. |
| Address | 100 Indigo Creek Drive<br>Rochester, New York 14626 |
| Phone number | 908-218-8173 |
| Fax number | 908-218-8168 |
| Establishment Registration Number | 1319681 |
| Name of contact person | Jessica Miller |
| Date prepared | August 26, 2015 |
| | Name of devices |
| Trade or proprietary name | VITROS Chemistry Products CRP Slides<br>VITROS Chemistry Products Calibrator Kit 7 |
| Common or usual name | C-reactive protein immunological test system |
| Classification name | C-reactive protein, antigen, antiserum, and control |
| Classification panel | Immunology |
| Regulation | 21 CFR 866.5270: C-Reactive Protein immunological test<br>system<br>21 CFR 862.1150: Calibrator<br>Classification: Class II |
| Product Code(s) | DCK, JIT |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | The VITROS Chemistry Products CRP Slides and VITROS<br>Chemistry Products Calibrator Kit 7 (modified) is substantially<br>equivalent to the VITROS Chemistry Products CRP Slides and<br>VITROS Chemistry Products Calibrator Kit 7 (current),<br>cleared March, 2003 (K030626). |
| Device description | The VITROS CRP Slide method is performed using the<br>VITROS CRP Slides and the VITROS Chemistry Products<br>Calibrator Kit 7 on VITROS Chemistry and Integrated<br>Systems.<br>The VITROS CRP Slide is a multilayered, analytical element<br>coated on a polyester support. The immuno-rate format for<br>CRP is based on an enzymatic heterogeneous, sandwich<br>immunoassay format. In this format a derivative of<br>phosphorylcholine (PC) is covalently bound to polystyrene<br>polymer beads and in the presence of calcium serves as a<br>capture agent. Monoclonal anti-CRP antibody conjugated to<br>horseradish peroxidase (HRP) serves as a signal generator.<br>A drop of patient sample is deposited on the slide and is evenly<br>distributed by the spreading layer to the underlying layers.<br>CRP in the sample binds to PC-linked capture beads and anti-<br>CRP antibody labeled with horseradish peroxidase to form an<br>insoluble sandwich complex in Incubation 1. The subsequent<br>addition of 12 $ \mu $ L of VITROS Immuno-Wash Fluid to the slide<br>removes unbound materials from the read area, while also<br>providing the hydrogen peroxide required for the enzyme-<br>mediated oxidation of leuco dye.<br>The reflection density of the dye is measured after the addition<br>of VITROS Immuno-Wash Fluid at the end of Incubation 2.<br>This reflection density is directly proportional to the<br>concentration of CRP in the sample. To determine if an<br>adequate wash has occurred, the wash detection dye is read at<br>540 nm immediately after Incubation 2.<br><br>The VITROS Calibrator Kit 7 is prepared from processed<br>human serum to which purified human C-reactive protein,<br>inorganic salts, and preservatives have been added.<br>The human blood products provided as components of<br>VITROS Calibrator Kit 7 have been tested at the individual<br>donor level and found nonreactive for hepatitis B surface<br>antigen (HBsAg), antibody to HCV, and antibody to HIV<br>using FDA approved methods. |
| Intended<br>Use/Indications for Use | CRP Slide:<br>For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products CRP Slides quantitatively<br>measure C-reactive protein (CRP) concentration in serum and<br>plasma using VITROS 250/350/5,1 FS and 4600 Chemistry<br>Systems and the VITROS 5600 Integrated System |
| C-reactive protein is synthesized by the liver and is one of the<br>acute phase proteins. In the acute phase response, increased | |
| concentrations of a number of plasma proteins, including CRP, | |
| are observed. CRP concentration measurements are useful in | |
| the detection and evaluation of inflammatory disorders, tissue | |
| injury, and infections. | |
| <b>Calibrator Kit 7:</b> | |
| <i>For in vitro</i> diagnostic use only. | |
| VITROS Chemistry Products Calibrator Kit 7 is used to | |
| calibrate VITROS 250/350/5,1 FS and 4600 Chemistry | |
| Systems and the VITROS 5600 Integrated System for the | |
| quantitative measurement of CRP. | |

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### Comparison with Predicate Devices:

## Table 1: VITROS Chemistry Products CRP Slides

| Characteristic | Predicate [VITROS CRP Slides<br>(Current), K030626] | New Device [VITROS CRP<br>Slides (Modified)] |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products CRP<br>Slides quantitatively measure C-<br>reactive protein (CRP) concentration<br>in serum and plasma using VITROS<br>250/350/950/5,1 FS and 4600<br>Chemistry Systems and the VITROS<br>5600 Integrated System. | For in vitro diagnostic use only.<br>VITROS Chemistry Products CRP<br>Slides quantitatively measure C-<br>reactive protein (CRP)<br>concentration in serum and plasma<br>using VITROS 250/350/5,1 FS and<br>4600 Chemistry Systems and the<br>VITROS 5600 Integrated System. |
| Basic Principle | Fixed-point immuno-rate | No Change |

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| Characteristic | Predicate [VITROS CRP Slides (Current), K030626] | New Device [VITROS CRP Slides (Modified)] |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Reagent<br>Composition | Reactive Ingredients:<br>Immobilized phosphorylcholine;<br>mouse anti-CRP<br>antibody labeled with horseradish<br>peroxidase; calcium<br>chloride; and 2-(3,5-dimethoxy-4-<br>hydroxyphenyl)-4,5-<br>bis(4-dimethylaminophenyl)<br>imidazole (leuco dye)<br><br>Other Ingredients:<br>Binders, buffer, surfactants, cross-<br>linking agent, polymer beads,<br>proteins, stabilizers and wash<br>detection dye. | No Change |
| Sample volume | 11 μL | No Change |
| Sample type | Serum, plasma | No Change |
| Assay Range<br>Serum, Plasma | 5 - 90 mg/L | No Change |
| Incubation time<br>and temperature | 7.5 minutes at 37°C | No Change |
| Calibration<br>Traceability of<br>Values (VITROS<br>Chemistry<br>Products<br>Calibrator Kit 7) | IRMM Reference Material ERM-<br>DA472 | IRMM Reference Material ERM-<br>DA474/IFCC |

## Table 1: VITROS Chemistry Products CRP Slides

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| Characteristic | Predicate [VITROS Calibrator Kit 7<br>(Current), K030626] | New Device<br>[VITROS Calibrator Kit 7<br>(Modified)] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products Calibrator<br>Kit 7 is used to calibrate VITROS<br>250/350/950/5,1 FS and 4600 Chemistry<br>Systems and the VITROS 5600 Integrated<br>System for the quantitative measurement<br>of CRP. | For in vitro diagnostic use<br>only.<br>VITROS Chemistry Products<br>Calibrator Kit 7 is used to<br>calibrate VITROS<br>250/350/5,1 FS and 4600<br>Chemistry Systems and the<br>VITROS 5600 Integrated<br>System for the quantitative<br>measurement of CRP. |
| Matrix/<br>Ingredients | Liquid; processed human serum to which<br>purified human C-reactive protein,<br>inorganic salts, and preservatives have<br>been added. | No Change |
| Traceability of<br>Values | IRMM Reference Material ERM-DA472…