ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL by ORION DIAGNOSTICA, DIV. ORION CORP.

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 Description

Orion Diagnostica QuikRead® CRP Kit and QuikRead CRP Control

AI/ML Overview

The provided document is a 510(k) premarket notification letter for the Orion Diagnostica QuikRead® CRP Kit and QuikRead CRP Control. It is a communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed study information required to answer your questions about acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter confirms substantial equivalence based on information submitted by the manufacturer, but it does not typically include the full technical and clinical study report itself. That information would be found in the manufacturer's 510(k) submission packet, which is much more extensive and generally not made public in detail alongside the clearance letter.

Therefore, I cannot provide the requested information from the given text.

To be clear:

1. A table of acceptance criteria and the reported device performance: Not available in this document.
2. Sample sized used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in this document. (This device is an in-vitro diagnostic kit for C-reactive protein, not an AI-assisted diagnostic imaging device for human readers.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. (This device is a quantitative assay, not an algorithm.)
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in black.

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

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(Per 21 CFR 801.109)	OR	Over-The-Cou(Optional For
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unter Use rmat 1-2-96)

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).