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K Number
K022176
Device Name
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
Manufacturer
ORION DIAGNOSTICA, DIV. ORION CORP.
Date Cleared
2002-12-03

(153 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 High Sensitivity CRP (HS-CRP) is an in vitro diagnostic assay intended for the quantification of low concentrations (ca. 0.25 - 10.0 mg/l) of C-reactive protein (CRP) in human serum or plasma (EDTA or heparin) by means of particle enhanced immunoturbidimetry using a Hitachi 911 or 917 analyzer. The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Orion Diagnostica High Sensitivity CRP (HS-CRP)" device. It states that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use for quantifying C-reactive protein in human serum or plasma.

However, the document does not contain the detailed information requested regarding:

  • Acceptance criteria and reported device performance (in a table format).
  • Sample size and provenance for test sets.
  • Number and qualifications of experts for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) study results or effect size.
  • Standalone algorithm performance.
  • Type of ground truth used (e.g., pathology, outcomes data).
  • Sample size for training sets.
  • Ground truth establishment for training sets.

This type of information is typically found in the 510(k) submission document itself, which is a much more extensive technical file than the clearance letter provided here. The clearance letter only confirms that the FDA has reviewed the submission and found the device substantially equivalent.

Therefore, I cannot fulfill your request for a table of acceptance criteria and study details based solely on the provided text.

§ 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).