VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS

K041799 · Ortho-Clinical Diagnostics, Inc. · NQD · Aug 25, 2004 · Immunology

Device Facts

• Record ID: K041799
• Device Name: VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: NQD · Immunology
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

VITROS Chemistry Products hsCRP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure Creactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L. VITROS Chemistry Products Calibrator Kit 17: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent. VITROS Chemistry Products hsCRP Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.

Device Story

VITROS Chemistry Products hsCRP Reagent is an in vitro diagnostic assay for quantitative CRP measurement in human serum/plasma; used on VITROS 5.1 FS Chemistry System. System utilizes latex particle-enhanced immunoturbidimetry; reagents combined with patient samples by automated analyzer. Output is quantitative CRP concentration; used by clinicians to assess coronary heart disease risk. System includes calibrators and assayed performance verifiers to monitor assay performance. Designed for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance validated via correlation study against predicate device (N High Sensitivity CRP assay) using patient samples; results showed linear regression of y = 0.954x + 0.063 mg/L with correlation coefficient of 0.993. Additional studies performed for precision, linearity, and specificity.

Technological Characteristics

Latex particle-enhanced immunoturbidimetry assay; liquid ready-to-use reagents. Traceable to CRM 470. Designed for use on VITROS 5.1 FS Chemistry System. Performance verifiers consist of human plasma base matrix with stabilizers and preservatives.

Indications for Use

Indicated for quantitative measurement of C-reactive protein (CRP) in human serum and plasma to evaluate coronary heart disease (CHD) risk. Risk increases with CRP values > 3 mg/L. Prescription use only.

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

• N High Sensitivity CRP assay (K033908)
• VITROS Chemistry Products CRP Performance Verifiers (K953197)

Submission Summary (Full Text)

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# 1.0 510(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: Ko41799

## 1.1 Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: [phone] Fax: [phone]

Contact Person: Carey A. Mayo, M.S., RAC

## 1.2 Date of Preparation: July 1, 2004

## 1.3 Device Proprietary Name(s)

Trade Name(s) VITROS Chemistry Products hsCRP Reagent VITROS Chemistry Products Calibrator Kit 17 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products hsCRP Performance Verifier I, II, and III

Common Name C-Reactive Protein assay and controls

## 1.4 Classification Name(s)

C-Reactive Protein Immunological Test System: Class II (21 CFR 866.5270) Assayed Controls: Class I, reserved (21 CFR 862.1660)

### 1.5 Predicate device

The VITROS Chemistry Products hsCRP assay is substantially equivalent to the N High Sensitivity CRP assay (Dade Behring, Inc.).

The VITROS Chemistry Products hsCRP Performance Verifiers are substantially equivalent to the VITROS Chemistry Products CRP Performance Verifiers.

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#### 1.6 Device description

The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

- 1. The VITROS 5.1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- 2. The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products hsCRP Reagent, VITROS Chemistry Products Calibrator Kit 17, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products hsCRP Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS hsCRP assay.
- 3. The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
- 4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

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#### 1.7 Device intended use

VITROS Chemistry Products hsCRP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure Creactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.

VITROS Chemistry Products Calibrator Kit 17: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.

VITROS Chemistry Products hsCRP Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.

#### Comparison to predicate device: Reagent Kit and Calibrators 1.8

The VITROS Chemistry Products hsCRP Reagent, VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products FS Calibrator 1 are substantially equivalent to the N High Sensitivity CRP Assay (Dade Behring, Inc.), which was cleared by FDA (K033908) for IVD use.

The relationship between the VITROS hsCRP assay and the predicate device, determined by least squares linear regression, is:

VITROS hsCRP assay = 0.954 X + 0.063 mg/L with a correlation coefficient of 0.993, where X is the predicate device.

In addition to the above mentioned correlation study, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS hsCRP assay, (refer to the VITROS Chemistry Products hsCRP Reagent Instructions for Use for summaries of the results of these studies).

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The table below lists the characteristics of the VITROS hsCRP Assay and the N High Sensitivity CRP Assay (Dade Behring, Inc.).

| Device<br>Characteristic | VITROS hsCRP Assay<br>(New device #1) | N High Sensitivity CRP Assay<br>(Predicate device #1) |
|--------------------------|---------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Quantitative measurement<br>of C-reactive protein (CRP) | Same |
| Basic principle | Latex particle enhanced<br>Immunoturbidimetry | Particle enhanced<br>immunonephelometry |
| Traceability | CRM 470 | CRM 470 |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry<br>System | Dade Behring BN ProSpec<br>System |
| Sample type | Serum and plasma (Heparin) | Serum and plasma (heparin and<br>EDTA) |

#### Comparison to predicate device: Performance Verifiers 1.9

VITROS Chemistry Products hsCRP Performance Verifiers are substantially equivalent to VITROS Chemistry Products CRP Performance Verifiers (predicate device) which were cleared by the FDA (K953197) for IVD use.

The table below lists the characteristics of the VITROS Chemistry Products hsCRP Performance Verifiers and the VITROS Chemistry Products CRP Performance Verifiers.

| Device<br>Characteristic | VITROS hsCRP<br>Performance Verifiers<br>(New device #2) | VITROS CRP Performance<br>Verifiers<br>(Predicate device #2) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VITROS hsCRP<br>Performance Verifiers are<br>assayed controls used to<br>monitor performance of<br>hsCRP Reagent on VITROS<br>5,1 FS Chemistry Systems. | VITROS CRP Performance<br>Verifier is an assayed control<br>used to monitor performance<br>on VITROS Chemistry<br>Systems. |
| Matrix | A base matrix of human<br>plasma and plasma proteins<br>to which stabilizers and<br>preservative have been<br>added. | A base matrix of human<br>serum to which purified<br>human C-reactive protein,<br>inorganic salts and<br>preservatives have been<br>added. |
| Levels | Low, Medium, and High | Low and High |

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# 1.10 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products hsCRP assay and the VITROS hsCRP Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carey A. Mayo, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101

AUG 2 5 2004

k041799 Re:

Trade/Device Name: VITROS Chemistry Products hsCRP Reagent VITROS Chemistry Products Calibrator Kit 17 VITROS Chemistry Products FS Calibrato VITROS Chemistry Products hsCRP Performance Verifiers I. II and III Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive protein immunological test system Regulatory Class: Class II Product Code: NQD, JIT, JJX Dated: July 1, 2004 Received: July 2, 2004

Dear Ms. Mayo:

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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### Page 2

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/dsmamain.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean 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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# 2.0 Indications for Use Statement

Page 1 of 1

| 510(k) Number (if known): | K041799 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | <ol><li>VITROS Chemistry Products hsCRP Reagent</li><li>VITROS Chemistry Products Calibrator Kit 17</li><li>VITROS Chemistry Products FS Calibrator 1</li><li>VITROS Chemistry Products hsCRP Performance Verifiers I, II, and III</li></ol> |
| Indications for Use: | <ol><li>For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.</li><li>&amp; 3. For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.</li><li>For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.</li></ol> |

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------------------------------|
| <div><img alt="Checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/AxMDAwMDAwMDw8DAwMDAwMAAQAH/AAJ4+4WAAAAAElFTkSuQmCC"/></div> | | ____________________ |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol Benem
Division Sign Off

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) K041799