C-REACTIVE PROTEIN (CRP)

K030899 · Abbott Laboratories · DCN · Jul 2, 2003 · Immunology

Device Facts

• Record ID: K030899
• Device Name: C-REACTIVE PROTEIN (CRP)
• Applicant: Abbott Laboratories
• Product Code: DCN · Immunology
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The C-Reactive Protein assay is used for the quantitative analysis of C-reactive protein in human serum and plasma.

Device Story

C-Reactive Protein assay is an in vitro diagnostic test for quantitative determination of C-reactive protein in human serum or plasma. Device utilizes latex-enhanced immunoturbidimetric technology; antigen-antibody reaction between sample CRP and anti-CRP adsorbed to latex particles causes agglutination. Agglutination is detected as an absorbance change proportional to CRP concentration. Concentration is determined via interpolation from a calibration curve. Used in clinical laboratory settings on the AEROSET System. Healthcare providers use results to evaluate tissue injury. Benefits include standardized quantitative assessment of inflammatory markers.

Clinical Evidence

Bench testing only. Comparative performance study on AEROSET System vs. Dade Behring N High Sensitivity CRP on BN 100. Correlation coefficient 0.996, slope 0.97, Y-intercept 0.07 mg/dL. Precision studies (within-run, between-run, between-day) showed total %CV ranging from 1.0% to 2.3% across three control levels. Assay range 0.22 to 30.00 mg/dL; limit of quantitation 0.216 mg/dL.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Measures intensity of transmitted light. Designed for use on the AEROSET System. Quantitative determination via calibration curve interpolation.

Indications for Use

Indicated for the quantitation of C-reactive protein in human serum or plasma to aid in the evaluation of the amount of injury to body tissues.

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

• Dade Behring N High Sensitivity CRP (K991385)

Submission Summary (Full Text)

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#### JUL 2 2003

# 510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | March 20, 2003 |
|--------------------------------------------------|--------------------|
| Device Trade or Proprietary Name: | C-Reactive Protein |
| Device Common/Usual Name or Classification Name: | C-Reactive Protein |
| Classification Number/Class: | DCN, Class II |

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:

#### Test Description:

C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum or plasma. The C-reactive protein is a latex enhanced immunoturbidimetric assay that involves an antigen-antibody reaction between the C-reactive protein in the sample and the anti-C-reactive protein, which has been adsorbed to latex particles. The resulting agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of C-reactive protein in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

Section II Page I

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### Substantial Equivalence:

The C-Reactive Protein assay is substantially equivalent to the Dade Behring N High Sensitivity CRP (K991385) on the Dade Behring BN™ 100.

Both assays yield similar Performance Characteristics.

Similarities:

- . Both assays are in vitro immunoassays.
- Both assays can be used for the quantitative determination of C-reactive protein in . human serum or plasma.
- Both assays yield similar clinical results. .
- . Both assays require calibration with calibrators.
- Both assays are based on the measurement of the agglutination following . antigen-antibody reaction.

### Differences:

- . There is a difference between the assay ranges.
- . The C-Reactive Protein assay measures the intensity of transmitted light. The Dade Behring N High Sensitivity assay measures the intensity of scattered light.

### Intended Use:

The C-Reactive Protein assay is used for the quantitative analysis of C-reactive protein in human serum and plasma.

C-Reactive Protein 510(k) 3/20/2003 CRP_S_RI.doc

Section II Page 2

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#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The C-Reactive Protein assay method comparison vielded acceptable correlation with the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100. On the AEROSET System, the correlation coefficient = 0.996, slope = 0.97, and the Y-intercept = 0.07 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using three levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 1.2 to 2.0%, Level 2 ranged from 1.0 to 2.3%, and Level 3 ranged from 1.0 to 1.3%. The C-Reactive Protein assay range is 0.22 to 30.00 mg/dL. The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.216 mg/dL on the AEROSET System. These data demonstrate that the performance of the C-Reactive Protein assay is substantially equivalent to the performance of the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100.

#### Conclusion:

The C-Reactive Protein assay is substantially equivalent to the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100 as demonstrated by results obtained in the studies.

Section II Page 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 2 2003

Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories ADD Regulatory Affairs 1920 Hurd Drive Irving, TX 75038

k030899 Re:

> Trade/Device Name: C-Reactive Protein Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: June 12, 2003 Received: June 16, 2003

Dear Ms. Morris:

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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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,

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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510(k) Number (if known): \$03089 g

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------------------------------------|
| Prescription Use | <span style="text-decoration: overline;">✓</span> |
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) |
| Division Sign-Off | <img alt="Signature" src="signature.png"/> |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| 510(k) | K030899 |

C-Reactive Protein 510(k) 3/20/2003 CRP_5_R1.doc