ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

K031607 · Orion Diagnostica, Div. Orion Corp. · DCK · Oct 10, 2003 · Immunology

Device Facts

• Record ID: K031607
• Device Name: ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
• Applicant: Orion Diagnostica, Div. Orion Corp.
• Product Code: DCK · Immunology
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using the QuikRead® 101 Instrument. Measurement of CRP helps to evaluate the acute inflammatory processes induced by infectious microbial agents or non-infectious inflammatory stimuli. QuikRead CRP Control is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use.

Device Story

The QuikRead CRP system is a quantitative in vitro diagnostic assay for C-reactive protein (CRP) levels in whole blood or plasma. It utilizes the QuikRead 101 Instrument to process samples. The system aids clinicians in evaluating acute inflammatory processes resulting from microbial infections or non-infectious stimuli. The device is intended for professional use in clinical settings. The QuikRead CRP Control is used to ensure the quality and accuracy of the assay performance on the instrument. By providing rapid quantitative CRP measurements, the system assists healthcare providers in assessing patient inflammatory status, thereby supporting clinical decision-making regarding infection management and inflammatory condition monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the quantitative assay.

Technological Characteristics

Quantitative immunoturbidimetric assay for CRP. System consists of the QuikRead CRP kit (reagents) and the QuikRead 101 Instrument. Designed for whole blood or plasma samples. In vitro diagnostic use.

Indications for Use

Indicated for quantitative measurement of C-reactive protein (CRP) in whole blood or plasma to evaluate acute inflammatory processes caused by infectious or non-infectious stimuli. For professional in vitro diagnostic use.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annikka Rantama Assistant Vice President, QA/RA Orion Diagnostica Koivumankkaan Tie 6 Espoo, 02200 Finland

OCT 1 0 2003

Re: k031607

Trade/Device Name: Orion Diagnostica QuikRead® CRP Kit and QuikRead CRP Control Regulation Number: 21 CFR § 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: II Product Code: DCK Dated: September 4, 2003 Received: September 8, 2003

Dear Ms. Rantama:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

iteven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

## 510(k) Number (if known): K031607

Device Name: Orion Diagnostica QuikRead® CRP kit and QuikRead CRP Control

Indications For Use:

Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using the QuikRead® 101 Instrument. Measurement of CRP helps to evaluate the acute inflammatory processes induced by infectious microbial agents or non-infectious inflammatory stimuli. QuikRead CRP Control is intended for quality control of the QuikRead

CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | J P Reeves for T.J.O'Leary |
|-----------------------------------------|----------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | KO 31607 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Cou<br>(Optional For |
|------------------------------------------|----|-------------------------------|
|------------------------------------------|----|-------------------------------|

unter Use rmat 1-2-96)