IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5

K990886 · Diagnostic Products Corp. · DCK · Apr 6, 1999 · Immunology

Device Facts

• Record ID: K990886
• Device Name: IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
• Applicant: Diagnostic Products Corp.
• Product Code: DCK · Immunology
• Decision Date: Apr 6, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

Device Story

IMMULITE® C-Reactive Protein is an in vitro diagnostic assay used with the IMMULITE® Automated Analyzer. It utilizes a two-site chemiluminescent enzyme immunometric principle to quantify CRP levels in serum or plasma samples. The device is intended for use in clinical laboratory settings by trained personnel. The analyzer processes the samples and provides quantitative results to healthcare providers, which are used as an aid in assessing the extent of tissue injury in patients. The system automates the immunoassay workflow, providing objective measurements to support clinical decision-making regarding inflammatory or injury-related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the technological and functional identity to the predicate device.

Technological Characteristics

Two-site chemiluminescent enzyme immunometric assay. Designed for use with the IMMULITE® Automated Analyzer. In vitro diagnostic reagent system.

Indications for Use

Indicated for the quantitative measurement of C-reactive protein (CRP) in human serum or plasma to aid in the evaluation of 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

• IMMULITE® C-Reactive Protein (K984132)

Submission Summary (Full Text)

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4-6-99

990886

## 510 (k) Summary Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Name: Address:

Telephone Number: Facsimile_Number:

Contact Person:

Date of Preparation:

Catalog Number:

Device Name Trade:

Common:

Classification:

Manufacturer:

Establishment Registration #:

Substantially Equivalent Predicate Device:

Description of Device:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

[phone] [phone]

Edward M. Levine, Ph.D. Director of Clinical Affairs

March 15, 1999

LKCR1, LKCR5

IMMULITE® C-Reactive Protein

Reagent system for the determination of C-reactive protein (CRP) in serum or plasma.

Class II device, 82-DCK (21 CFR 866.5270)

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597

DPC Registration number is 2017183

IMMULITE® C-Reactive Protein (K984132)

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer

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## Intended Use of the Device:

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

#### Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® C-Reactive Protein.

Edward M. Lewis, Ph.D.

Edward M. Levine, Ph.D Director of Clinical Affairs

3/15/89
Date

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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APR 6 1399

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward M. Levine, Ph.D. Director, Clinical Affairs DIAGNOSTIC PRODUCTS CORPORATION 5700 West 96th Street Los Angeles, CA 90045

Re: K990886 Trade Name: IMMULITE® C-Reactive Protein Regulatory Class: II Product Code: DCK March 15, 1999 Dated: Received: March 17, 1999

Dear Dr. Levine:

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 Requlations, 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 requlatory 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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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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990886 510(k) Number (if known): Device Name: IMMULITE® C-Reactive Protein

Indications For Use:

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Arthur E. Makin

sion Sign-Off) sion of Clinical Laboratory Devices 990886 (k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-

96)