LogoFDA 510(k) Search
K Number
K991224
Device Name
K-ASSAY CRP
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-05-14

(32 days)

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

The K-ASSAY CRP Assay is intended to be used for the quantitative determination of CRP in serum by immunoturbidimetric assay. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. FOR IN VITRO DIAGNOSTIC USE.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a device called "K-ASSAY CRP." This document primarily addresses the regulatory approval process and states the device's intended use.

It does not contain any information regarding:

  • Acceptance criteria and reported device performance in a table.
  • Sample sizes, data provenance, or details about the test set.
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text. This document is a regulatory approval, not a scientific study report describing the validation of the device.

§ 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).