CRP

K991372 · Abbott Laboratories · DCN · Jun 1, 1999 · Immunology

Device Facts

• Record ID: K991372
• Device Name: CRP
• Applicant: Abbott Laboratories
• Product Code: DCN · Immunology
• Decision Date: Jun 1, 1999
• 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 quantitation of C-reactive protein in human serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Device Story

The C-Reactive Protein (CRP) assay is an in vitro diagnostic test used on the AEROSET™ System. It measures CRP concentration in human serum and plasma samples. The principle of operation is immunoturbidimetric: antigen in the sample binds to specific antibodies in the reagent, forming immune complexes. These complexes increase light scattering, which is measured via turbidity at 340 nm and 700 nm. The resulting measurement correlates to CRP concentration. The device is intended for use by clinical laboratory professionals. Healthcare providers use the quantitative output to assess the extent of tissue injury in patients. The assay provides a diagnostic tool for evaluating inflammatory states or tissue damage.

Clinical Evidence

Bench testing only. Method comparison study against the predicate (Hitachi 717 Analyzer) showed a correlation coefficient of 0.9963, slope of 1.093, and Y-intercept of 0.203 mg/dL. Precision studies (within-run, between-run, between-day) using two control levels yielded total %CVs of 4.5% and 2.8%. The assay range is up to 12.68 mg/dL with a limit of quantitation (sensitivity) of 0.263 mg/dL.

Technological Characteristics

In vitro immunoturbidimetric assay. Measures light scattering at 340 nm and 700 nm. Designed for use on the AEROSET™ System. Quantitative measurement of CRP in serum/plasma.

Indications for Use

Indicated for the quantitative determination of C-reactive protein in human serum and 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

• Boehringer Mannheim C-Reactive Protein assay (K930621)

Submission Summary (Full Text)

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# 510(k) Summary

#### Contact Person Submitter's Name/Address Linda Morris Abbott Laboratories Senior Regulatory Specialist MS 1-8 1920 Hurd Drive Regulatory Affairs Irving, Texas 75038 [phone] Fax [phone]

| Date of Preparation of this Summary: | April 19, 1999 |
|--------------------------------------------------|--------------------|
| Device Trade or Proprietary Name: | CRP |
| Device Common/Usual Name or Classification Name: | C-Reactive Protein |
| Classification Number/Class: | 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: K991372-

### Test Description:

C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 340 nm and 700 nm, which correlates with the concentration of C-reactive protein in the sample.

#### Substantial Equivalence:

The C-Reactive Protein assay is substantially equivalent to the Boehringer Mannheim® C-Reactive Protein assay (K930621) on the Hitachi® 717 Analyzer.

C-Reactive Protein 510(k) April 19, 1999 Сгр

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These assays yield similar Performance Characteristics.

Similarities:

- Both assays are in vitro immunoturbidimetric methods. .
- Both assays can be used for the quantitative determination of C-reactive . protein.
- Both assays yield similar clinical results. .
- Both assays are based on the light scattering properties of antigen-antibody . complexes.

Differences:

- There is a difference in the assay range. .
### Intended Use:

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

## Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System.. The C-Reactive Protein assay method comparison yielded acceptable correlation with the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9963, slope = 1.093, and the Y-intercept = 0.203 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 control is 4.5% and Level 2/Panel 402 is 2.8%. The C-Reactive Protein assay range is up to 12.68 mg/dL. The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.263 mg/dL. These data demonstrate that the performance of the C-Reactive Protein assay is substantially equivalent to the performance of the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer.

C-Reactive Protein 510(k) April 19, 1999 Стр

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# Conclusion:

The C-Reactive Protein assay is substantially equivalent to the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

C-Reactive Protein 510(k) April 19, 1999
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

| |099 JUN

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

Re: K991372 Trade Name: C-Reactive Protein (CRP) Regulatory Class: II Product Code: DCN Dated: April 19, 1999 Received: April 20, 1999

Dear Ms. Morris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): H99 |372-

C-Reactive Protein Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Peter E. Mdeum
(Division Sign-Off)

linical Laboratory Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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