IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

K981638 · Beckman Coulter, Inc. · DCK · Jun 12, 1998 · Immunology

Device Facts

• Record ID: K981638
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: DCK · Immunology
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The IMMAGE® Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System CRP reagent is an in vitro diagnostic assay used with the Beckman Coulter IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure CRP concentrations in human serum and plasma samples. The system employs latex particle-enhanced immunochemistry; the reagent contains goat anti-CRP antibodies. The device is intended for use in clinical laboratory settings by trained personnel. The system automatically processes samples, measures light scattering (nephelometry), and calculates CRP concentration. Results are provided to clinicians to assist in the evaluation of physiological stress, trauma, infection, inflammation, and post-surgical status. The liquid-stable reagent format offers improved stability compared to lyophilized alternatives.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison, stability, linearity, and imprecision studies. Imprecision testing (N=80 per level) showed within-run %C.V. ranging from 2.6% to 11.1% and total imprecision %C.V. ranging from 3.0% to 12.1% across three concentration levels (0.35 to 6.69 mg/dL).

Technological Characteristics

Liquid-stable reagent containing goat anti-CRP antibodies. Utilizes rate nephelometry and latex particle-enhanced immunochemistry. Designed for use on the Beckman Coulter IMMAGE Immunochemistry System. No specific ASTM material standards cited.

Indications for Use

Indicated for the quantitative determination of human C-reactive protein (CRP) in human serum and plasma to aid in the evaluation of stress, trauma, infection, inflammation, and surgery.

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

• Behring N Latex CRP (K962523)

Submission Summary (Full Text)

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JUN 12 1998

# BECKMAN

K981638

### Summary of Safety & Effectiveness IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent

#### 1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

May 7, 1998

#### 3.0 Device Name(s):

- 3.1 Proprietary Names
IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent

#### 3.2 Classification Name

C-Reactive Protein immunological test system (21 CFR § 866.5270)

#### 4.0 Predicate Device(s):

| IMMAGE System<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|------------------------------------------------------|---------------------|----------------------|------------------|
| IMMAGE System<br>C-Reactive Protein<br>(CRP) Reagent | Behring N Latex CRP | Behring Diagnostics* | K962523 |

* Behring Diagnostics (Westwood, MA)

#### 5.0 Description:

The IMMAGE Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE® Immunochemistry System.

#### 6.0 Intended Use:

The IMMAGE® Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.

### Beckman Instruments, Inc.

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#### Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. A STATISTIC COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTI

| | SIMILARITIES | |
|------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IMMAGE System<br>CRP Reagent | Intended Use | Same as Behring<br>N Latex CRP |
| | Nephelometric methodology | |
| | Use of Latex particle<br>technology | |
| | DIFFERENCES | |
| IMMAGE System<br>CRP Reagent | Form of reagent | the IMMAGE CRP is liquid stable<br>while Behring N Latex CRP<br>reagent is lyophilized |
| | Antibody source | IMMAGE CRP uses goat while<br>Behring N Latex CRP uses rabbit. |
| | Stability | IMMAGE CRP is stable for 30<br>days once opened, properly stored<br>while Behring N Latex CRP<br>reagent is stable for one week<br>following reconstitution. |

#### Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

### Method Comparison Study Results IMMAGE C-Reactive Protein (CRP) Reagent

| <br><br><br><br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>Taxas <br>Панаваларускаяния марактеническа чемка Геонин - уческа.<br>TERI NAMECARANAABES ES SEES TERREAP ******************************************************************************************************************************************<br><br> | <br>.<br><br><br><br><br><br><br> | ABBERTY THE SECREES CORRESS & C<br><br><br><br><br> | <br><br><br><br><br>.<br>инианначеннаяванаявандаряннаямиямиямия<br>LELARSHIP WANNER FRANCE PARKERSANTED<br>したときに無理なかったりとなるならマンチを見てると思います。<br>**************************************************** | <br>.<br><br>. habbelleres<br>. BALLES<br><br><br><br><br><br><br> | <br><br><br><br><br><br><br><br><br><br>ARESSALESS FORESSES<br><br><br><br> | <br><br>******************************************************************************************************************************************************************************<br>(xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx<br>.<br><br>> > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > ><br>****************************************************************************************************************************************************************************** |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | | |

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.35 | 0.039 | 11.1 | 80 |
| Level 2 | 4.95 | 0.129 | 2.6 | 80 |
| Level 3 | 6.69 | 0.236 | 3.5 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.35 | 0.043 | 12.1 | 80 |
| Level 2 | 4.95 | 0.149 | 3.0 | 80 |
| Level 3 | 6.69 | 0.266 | 4.0 | 80 |

## Estimated Improvision

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.

JUN 1 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 Brea, California 92822-8000

Re : K981638

> IMMAGE® Immunochemistry System C-Reactive Protein Trade Name: (CRP) Reagent

Regulatory Class: II Product Code: DCK Dated: May 7, 1998 Received: May 8, 1998

Dear Ms. Hellie:

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 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 requlations 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 requirement, 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 Druq 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 Requlations.

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Paqe 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 requlation 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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):

K9816638

Device Name: IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent

Indications for Use:

The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human Creactive protein concentrations in human serum and plasma samples by rate nephelometry.

Clinical Significance:

Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div><img alt="signature" src="signature"/></div> <div>(Division Sign-Off)</div> <div>Division of Clinical Laboratory Devices</div> <div>510(k) Number</div> | K981638 |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|

| Prescription Use | OR | Over-the-Counter Use |
|----------------------|----|------------------------|
| (per 21 CFR 801.109) | | Optional Format 1-2-96 |