REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE

K990825 · Dade Behring, Inc. · DCN · Apr 16, 1999 · Immunology

Device Facts

• Record ID: K990825
• Device Name: REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: DCN · Immunology
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure Creactive protein in human serum and plasma. Measurements of C-reactive protein are used in the evaluation of the amount of injury to body tissues.

Device Story

RCRP Flex™ reagent cartridge is an in vitro diagnostic assay used on the Dimension® clinical chemistry system. It utilizes a particle enhanced turbidimetric immunoassay (PETIA) technique; latex particles coated with goat polyclonal antibodies aggregate in the presence of C-Reactive Protein (CRP) in patient serum or plasma samples. The resulting increase in turbidity is measured; a mathematical function converts this measurement into a CRP concentration value. The device is intended for use in clinical laboratory settings by trained personnel. The quantitative output assists healthcare providers in assessing the degree of tissue injury in patients. The system provides automated analysis of patient samples to support clinical decision-making regarding inflammatory or injury-related conditions.

Clinical Evidence

Clinical performance was established via a split-sample comparison between the RCRP Flex™ reagent cartridge on the Dimension® clinical chemistry system and the predicate N Latex CRP mono assay. Testing involved 221 clinical patient samples. Results showed a correlation coefficient of 0.998, a slope of 0.95, and an intercept of -0.13 mg/L.

Technological Characteristics

In vitro diagnostic reagent cartridge; utilizes particle enhanced turbidimetric immunoassay (PETIA) technology; goat polyclonal antibody coating on latex particles; quantitative measurement via turbidimetric aggregation; designed for use on the Dimension® clinical chemistry system.

Indications for Use

Indicated for the quantitative measurement of C-reactive protein in human serum and plasma to evaluate the extent of body tissue injury.

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 Latex CRP mono assay (K962523)

Submission Summary (Full Text)

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K990825-

4/10/99

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

# DADE BEHRING

## Summary of Safety and Effectiveness Information

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.

| Submitter's Name: | Lorraine Piestrak | |
|--------------------------|-----------------------------------------------------------|--|
| | Dade Behring Inc. | |
| | P.O. Box 6101 | |
| | Newark, DE 19714-6101 | |
| Date of Preparation: | March 11, 1999 | |
| Name of Product: | Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge | |
| FDA Classification Name: | C-Reactive Protein Test System | |
| Predicate Device: | N Latex CRP mono assay (K962523) | |

Device Description: The RCRP method is based on a particle enhanced turbidmetric immunoassay (PETIA) technique. Latex particles coated with antibody to C-Reactive Protein aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration. The concentration is determined by means of a mathematical function.

Intended Use: The RCRP Flex™ reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure C-Reactive Protein in human serum and plasma.

### Comparison to Predicate Device:

| Item | RCRP Flex™ reagent cartridge | N Latex CRP mono |
|-------------|-----------------------------------------------------------|----------------------------------------------|
| Sample Type | serum and plasma | serum and plasma |
| Technology | particle enhanced<br>turbidimetric immunoassay<br>(PETIA) | particle agglutination<br>immunonephelometry |
| Antibody | goat polyclonal | mouse monoclonal |
| Detection | Aggregation (turbidimetric)<br>measurement | Agglutination<br>measurement |

## Comments on Substantial Equivalence:

Split sample comparison between the RCRP Flex™ reagent cartridge on the Dimension® clinical chemistry system and the N Latex CRP mono assay gave a correlation coefficient of 0.998, slope of 0.95, and an intercept of -0.13 mg/L [-1.3mg/L] when tested with 221 clinical patient samples.

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## DADE BEHRING

Conclusion: The RCRP Flex™ reagent cartridge is substantially equivalent in principle and performance to the N Latex CRP mono assay based on the split sample comparison discussed above.

Lorraine Pastrack

Lorraine Piestrak Quality Assurance and Compliance Manager March 11, 1999

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

APR 1 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorraine Piestrak Quality Assurance and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101

K990825 Re:

> Trade Name: Revised C-Reactive Protein (RCRP) Flex™ Reagent Cartridge Regulatory Class: II Product Code: DCN Dated: March 11, 1999 Received: March 12, 1999

Dear Ms. Piestrak:

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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Page 2

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 Sutman

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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#### Indications For Use Statement

Device Name: Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge

#### Indications for Use:

The Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure Creactive protein in human serum and plasma. Measurements of C-reactive protein are used in the evaluation of the amount of injury to body tissues.

Lorraine Pastore

Lorraine Piestrak Quality Assurance and Compliance Manager

March 11, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(División Sign-Off)
Division of Clinical Laboratory Devices 119988825
510(k) Number

Prescription Use سل (Per 21 CFR 801.109)

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OR

Over-the-counter Use

(Optional format 1-2-96)