VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7

K030626 · Ortho-Clinical Diagnostics, Inc. · DCK · Mar 18, 2003 · Immunology

Device Facts

• Record ID: K030626
• Device Name: VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DCK · Immunology
• Decision Date: Mar 18, 2003
• 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. Vitros Chemistry Products Calibrator Kit 7 For in vitro diagnostic use only. Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros Chemistry Systems for the quantitative measurement of CRP.

Device Story

Vitros Chemistry Products CRP Slides are dry, multilayered analytical elements used with Vitros Chemistry Systems (Vitros 250/950) to measure CRP concentration in serum or plasma samples. The system utilizes reflectance spectrophotometry to quantify the reaction within the slide. The process involves an immunological reaction between CRP in the patient sample and immobilized phosphorylcholine and anti-CRP antibody labeled with horseradish peroxidase (HRP). The system is operated by laboratory personnel in a clinical setting. The output is a quantitative CRP concentration value, which assists clinicians in detecting and evaluating inflammatory disorders, tissue injury, and infections.

Clinical Evidence

Bench testing only. Performance was demonstrated using manufactured slides tested with patient and quality control samples spanning the reportable range (0.3–11.0 mg/dL). No clinical prospective or retrospective studies were required for this modification.

Technological Characteristics

Dry, multilayered slide technology; reflectance spectrophotometry sensing. Reactive ingredients per cm2: immobilized phosphorylcholine (0.07 mg), anti-CRP antibody labeled with HRP (0.0006 units), calcium chloride (0.08 mg), leuco dye (0.04 mg). Incubation: 7.5 minutes at 37°C. Compatible with Vitros 250 and 950 Chemistry Systems.

Indications for Use

Indicated for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma to aid in the detection and evaluation of inflammatory disorders, tissue injury, and infections.

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 (current slide) (K953197)

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: 103062

- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive Name, Rochester, New York 14626-5101 Address, [phone] Contact
Contact Person: Darlene J. Phillips

- Date Special 510(k) prepared: 25 February2003 2. Preparation Date
- Trade or Proprietary Name: 3. Device Vitros Chemistry Products CRP Slides name Common Name: CRP test Classification Name: C-reactive protein immunological test system (21 CFR 866.5270)
- The Vitros Chemistry Products CRP Slides (modified) and Vitros 4. Predicate Chemistry Products Calibrator Kit 7 are substantially equivalent to the Vitros Chemistry Products CRP Slides (current slide) and Vitros Chemistry Products Calibrator Kit 7.

Continued on next page

Ortho-Clinical Diagnostics, Inc.

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## 510(k) Summary, Continued

| 5. Device<br>description | The Vitros Chemistry System uses Vitros Slides to perform discrete<br>chemistry tests on body fluid specimens. All reactions necessary for a<br>single quantitative measurement take place within the multilayered<br>analytical element of a Vitros slide.<br><br>The system is comprised of two main elements:<br><br>1. The range of Vitros Chemistry Products (in this case Vitros Chemistry<br>Products CRP Slides and Vitros Chemistry Products Calibrator Kit 7),<br>which are combined on the Vitros Chemistry System to perform the<br>Vitros CRP assay.<br><br>2. The Vitros Chemistry System - instrumentation, which provides<br>automated use of the chemistry slides. Vitros 250 and 950 Chemistry<br>Systems were cleared for market by separate 510(k) pre-market<br>notifications (K922072 and K946090, respectively).<br><br>The Vitros Chemistry System and Calibrators are dedicated specifically<br>for use only with the Vitros Chemistry Products range of products.<br><br>The Vitros System uses common reagents. The Vitros Chemistry Products<br>Specialty Diluent and Vitros ImmunoWash fluid were cleared by previous<br>510(k) pre-market notification (K962235 and K942610, respectively). |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. Device<br>intended use | Vitros Chemistry Products CRP Slides<br>For in vitro diagnostic use only.<br>Vitros Chemistry Products CRP Slides quantitatively measure C-reactive<br>protein (CRP) concentration in serum and plasma.<br><br>Vitros Chemistry Products Calibrator Kit 7<br>For in vitro diagnostic use only.<br>Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros<br>Chemistry Systems for the quantitative measurement of CRP. |

Continued on next page

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### 510(k) Summary, Continued

#### The Vitros Chemistry Products CRP Slides (modified) 7. Comparison to and Vitros Chemistry Products Calibrator Kit 7 are substantially predicate equivalent to Vitros Chemistry Products CRP Slides (current) and Vitros device Chemistry Products Calibrator Kit 7 which were cleared by the FDA for in vitro diagnostic use with human serum and plasma. (K953197, cleared July 31, 1995)

Table 1 lists the characteristics of the tests performed using the Vitros Chemistry Products CRP Slides (modified) and Vitros Chemistry Products CRP Slides (current slide).

| Table 1 List of Assay Characteristics: Comparison to Predicate Device | | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Characteristic | New Device | Predicate Device |
| Device Characteristic | New Device<br>Vitros CRP Slide<br>(Modified) | Predicate Device<br>Vitros CRP Slide<br>(Current) |
| Sample Volume | No Change. | 11 µL |
| Wash volume | No change | 12 µL |
| Intended Use | No Change. | For in vitro diagnostic use only.<br>Vitros CRP Slides quantitatively<br>measure C-reactive protein (CRP)<br>concentration in serum and plasma. |
| Basic Principle | No Change. | Dry multi-layered slide utilizing<br>reflectance spectrophotometry. |
| Sample Type | Serum<br>Plasma (heparin and EDTA) | Serum<br>Plasma (lithium heparin,<br>sodium citrate and EDTA) |
| Reportable Range Serum, Plasma | 0.3 - 11.0 mg/dL (Conv. Units)<br>3 - 110 mg/L (SI Units)<br>300 - 11000 ug/dL (Alt. Units) | 0.7 - 110.0 mg/dL (Conv. Units)<br>7 - 110 mg/L (SI Units)<br>700 - 11000 ug/dL (Alt. Units) |
| Instrumentation | No Change. | Vitros 250 and 950 Chemistry Systems |
| Incubation time and temperature | No Change. | 7.5 minutes at 37°C |
| Slide Reactive Ingredients per cm2: | | |
| Immobilized phosphorylcholine | No change | 0.07 mg |
| Anti-CRP antibody labeled with HRP | 0.0006 units | 0.0009 units |
| Calcium chloride | 0.08 mg | 0.10 mg |
| Leuco dye | No change | 0.04 mg |

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Vitros Chemistry Products CRP Slides Vitros Chemistry Products Calibrator Kit 7

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### 510(k) Summary, Continued

### The information presented in the pre-market notification demonstrate 8. Conclusion that the performance of the Vitros Chemistry Products CRP Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured CRP values spanning the reportable range.

The information presented in the premarket notification provide a reasonable assurance that the Vitros Chemistry Products CRP Slides (modified) is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the profiles, creating a sense of unity and human connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.

MAR 1 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Darlene J. Phillips Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

> k030626 Trade/Device Name: VITROS Chemistry Products CRP Slide and VITROS Chemistry Products Calibrator Kit 7 Regulation Number: 21 CFR § 866.5270 Regulation Name: C-reactive protein immunological test systems Regulatory Class: II Product Code: DCK, JIT Dated: February 25, 2003 Received: February 27, 2003

Dear Ms. Phillips:

Re:

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). 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.

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Page 2 -

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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Statement of Intended Use

Page 1 of 1

| 510(k) Number (if known): | K030626 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Vitros Chemistry Products CRP Slides<br>Vitros Chemistry Products Calibrator Kit 7 |
| Intended Use: | Vitros Chemistry Products CRP Slides<br>For in vitro diagnostic use only.<br>Vitros Chemistry Products CRP Slides quantitatively measure<br>C-reactive protein (CRP) concentration in serum and plasma.<br>Vitros Chemistry Products Calibrator Kit 7<br>For in vitro diagnostic use only.<br>Vitros Calibrator Kit 7 is intended for use in the calibration of<br>the Vitros Chemistry Systems for the quantitative measurement<br>of CRP. |
| Summary and<br>Explanation of Test | C-reactive protein is synthesized by the liver and is one of the<br>acute phase proteins. In the acute phase response, increased<br>concentrations of a number of plasma proteins, including CRP,<br>are observed. ¹<br>CRP concentration measurements are useful in the detection and<br>evaluation of inflammatory disorders, tissue injury, and<br>infections. ^{2, 3} |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Reeves for J. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030626

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1-2-96)

Vitros Chemistry Products CRP Slides Vitros Chemistry Products Calibrator Kit 7