QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

• K Number: K142993
• Device Name: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
• Manufacturer: ORION DIAGNOSTICA OY
• Date Cleared: 2016-03-10 ( 511 days)
• Product Code: DCK , JJQ , JJX
• Regulation Number: 866.5270
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

QuikRead go® CRP: The QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma and in serum samples. The test is carried out by means of the QuikRead go® instrument. Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use.

QuikRead go® CRP Control Set: The QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go® CRP assay with the QuikRead go® Instrument. For in vitro diagnostic use.

QuikRead go® CRP Verification Set: The QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. This assayed verification material is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. For in vitro diagnostic use.

QuikRead go® Instrument: The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system. The QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. Not for point-of-care use.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for the QuikRead go® CRP system, which includes the QuikRead go® CRP assay, Control Set, Verification Set, and Instrument. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or the study details to prove the device meets those criteria.

The provided text only outlines the indications for use of the various components of the QuikRead go® CRP system and regulatory information from the FDA. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Details on the type of ground truth used (e.g., pathology, outcomes data).
6. Sample size for the training set or how its ground truth was established.

To obtain this information, one would typically need to refer to the full 510(k) submission, specifically the sections detailing analytical and clinical performance studies, which are not included in this FDA clearance letter.

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).