NYCOCARD CRP CONTROL

K014084 · Primus Corp. · DCK · Jan 7, 2002 · Immunology

Device Facts

• Record ID: K014084
• Device Name: NYCOCARD CRP CONTROL
• Applicant: Primus Corp.
• Product Code: DCK · Immunology
• Decision Date: Jan 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-ofcare test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

Device Story

NycoCard CRP Control is an assayed human serum control material; used to monitor and evaluate precision and accuracy of quantitative C-reactive protein (CRP) assays. Primarily intended for use with the NycoCard CRP point-of-care test system. Device provides a known reference to verify system performance; aids clinicians in assessing CRP levels, which reflect body tissue injury. Used in clinical laboratory or point-of-care settings by healthcare professionals to ensure diagnostic test reliability.

Clinical Evidence

No clinical data; bench testing only. The device is an assayed control material used for quality assurance of an in vitro diagnostic test system.

Technological Characteristics

Assayed human serum control material. Designed for use with the NycoCard CRP point-of-care test system. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as an assayed human serum control material to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays, specifically for the NycoCard CRP point-of-care test system.

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.

Reference Devices

• NycoCard CRP point-of-care test system (K013787)

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 0 7 2002

Jimmie K. Noffsinger, Ph.D. Vice President - Research & Development Primus Corporation P.O. Box 22599 Kansas City, MO 64113

Re: k014084

> Trade/Device Name: NycoCard® CRP Control Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: December 11, 2001 Received: December 11, 2001

Dear Dr. 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.

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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 Gutman

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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## INTENDED USE STATEMENT:

| 510(k) Number: | K014084 |
|----------------|----------------------|
| Device Name: | NycoCard CRP Control |

Indications For Use:

The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-ofcare test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

FAX: [phone]

Ollachitt

(Division Sign-Off) Division of Clinical Laborator KO1401 510(k) Number

PO Box 22599

Kansas City, MO 64113

816-523-7491

900.27

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