QUIKREAD CRP CALIBRATOR SET

K042625 · Orion Diagnostica, OY · JJY · Nov 18, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042625
• Device Name: QUIKREAD CRP CALIBRATOR SET
• Applicant: Orion Diagnostica, OY
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.

Device Story

The Orion Diagnostica QuikRead CRP Verification Set consists of three levels of human-serum-based control materials (low, medium, high) used to verify calibration and validate methods for the QuikRead CRP System. The device is used by laboratory personnel in a clinical setting. The user processes the verification material in the same manner as a clinical whole blood specimen according to the QuikRead CRP test procedure. The resulting values are compared against lot-specific expected values provided on the vial labels to ensure system accuracy and performance. This process supports compliance with CLIA regulations regarding method validation and calibration verification.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Quality control material for in vitro diagnostic use. Formulated for verification of calibration and method validation of the QuikRead CRP System. Class I device under 21 CFR 862.1660.

Indications for Use

Indicated for verification of calibration and method validation of the QuikRead CRP System in a clinical laboratory setting.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized image of an eagle in flight, with three curved lines representing the bird's body and wings. The eagle is facing to the right. Surrounding the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion.

NOV 1 8 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 Espoo, Finland 02200

Re: k042625

Trade/Device Name: Orion Diagnostica QuikRead® CRP Verification Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 25, 2004 Received: October 27, 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. Iisting 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).

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

## Page 2 -

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,

Sincerely yours,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

## 510(k) Number (if known): K042625

Device Name: Orion Diagnostica QuikRead® CRP Verification Set

The Orion Diagnostica QuikRead CRP Verification Set is intended for Indications For Use: verification of calibration and method validation of the QuikRead CRP System.

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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert Sat

Office of In Vitro Diagnostic Device Evaluation

510(k) K042625