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K Number
K031607
Device Name
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
Manufacturer
ORION DIAGNOSTICA, DIV. ORION CORP.
Date Cleared
2003-10-10

(141 days)

Product Code
DCK
Regulation Number
866.5270
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 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.

§ 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).