NYCOCARD CRP

K013787 · Primus Corp. · DCK · May 14, 2002 · Immunology

Device Facts

• Record ID: K013787
• Device Name: NYCOCARD CRP
• Applicant: Primus Corp.
• Product Code: DCK · Immunology
• Decision Date: May 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

NycoCard® CRP Test system is an in vitro diagnostic device for the quantification of Creactive protein (CRP) in human serum, plasma, and whole blood by a solid phase, sandwich-format, immunometric assay. The measurement of CRP aids in evaluation of sandwish inflammatory process induced by infectious microbial agents or by noninfectious inflammatory stimuli.

Device Story

NycoCard® CRP is an in vitro diagnostic test system for quantifying C-reactive protein (CRP) in human serum, plasma, or whole blood. It utilizes a solid-phase, sandwich-format immunometric assay. The device is intended for use by healthcare professionals to assist in evaluating inflammatory processes. The test provides a quantitative measurement of CRP levels, which clinicians use to assess the presence or severity of inflammation resulting from infectious or non-infectious stimuli.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's intended use and technological characteristics as an in vitro diagnostic test system.

Technological Characteristics

Solid-phase, sandwich-format immunometric assay for CRP quantification. Analyzes human serum, plasma, and whole blood. In vitro diagnostic device.

Indications for Use

Indicated for the quantification of C-reactive protein (CRP) in human serum, plasma, and whole blood to aid in the evaluation of inflammatory processes caused by infectious microbial agents or noninfectious inflammatory stimuli.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jimmie K. Noffsinger Vice President, Research and Development Primus Corporation P.D. Box 22599 Kansas City, Missouri 64113

Re: k013787

Trade/Device Name: NycoCard® CRP Regulation Number: 21 CFR § 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: II Product Code: DCK Dated: March 13, 2002 Received: March 14, 2002

Dear Mr. Noffsinger:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INTENDED USE STATEMENT:

510(k) Number:

K013787

NycoCard® CRP CRP ------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:

Indications For Use:

NycoCard® CRP Test system is an in vitro diagnostic device for the quantification of Creactive protein (CRP) in human serum, plasma, and whole blood by a solid phase, sandwich-format, immunometric assay. The measurement of CRP aids in evaluation of sandwish inflammatory process induced by infectious microbial agents or by noninfectious inflammatory stimuli.

Jean Congn

(Divisic
n-Off)
Divisio Cascal Laboratory Devices
510(k) Naraber K013787

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|---------|--------------------------------------------------|
| (Division Sign-Off) | | |
| Division of Clinical Laboratory Devices | | |
| 510(k) Number | K013787 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use<br>(Optional Format 1-2-96) |