QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

K042442 · Orion Diagnostica, OY · DCK · Sep 24, 2004 · Immunology

Device Facts

• Record ID: K042442
• Device Name: QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
• Applicant: Orion Diagnostica, OY
• Product Code: DCK · Immunology
• Decision Date: Sep 24, 2004
• Decision: SESE
• Submission Type: Special
• 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 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 Set is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use.

Device Story

QuikRead CRP is a quantitative in vitro diagnostic assay for C-reactive protein (CRP) levels in whole blood or plasma. The system utilizes the QuikRead 101 Instrument to process samples. The device measures CRP to assist clinicians in evaluating acute inflammatory processes, whether induced by infectious microbial agents or non-infectious inflammatory stimuli. The QuikRead CRP Control Set is used for quality control of the assay. The system is intended for professional use in clinical settings to aid in clinical decision-making regarding inflammatory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunological test system for CRP; quantitative assay; utilizes QuikRead 101 Instrument for analysis; compatible with whole blood or plasma samples.

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

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

Public Health Service

SEP 2 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annikka Rantama Assistant Vice President Quality Assurance and Regulatory Affairs Orion Diagnostica Oy Koivumankkaan tie 6 02200 Espoo Finland

k042442 Re:

Trade/Device Name: Orion Diagnostica QuikRead® CRP kit OuikRead CRP Control Set Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK, JJX Dated: September 2, 2004 Received: September 9, 2004

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).

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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.

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,

Jean M. Cooper, US, DVM.

Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K042442

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using 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 Set is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument.

For in vitro diagnostic use.

Prescription Use ___x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Ace of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Camphorrence of CDAH
Division Sign-Off

of in Vitro Diaring

510(k) K072442