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K Number
K991210
Device Name
K-ASSAY CRP CALIBRATOR SET
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-05-11

(32 days)

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

The K-ASSAY CRP Calibrator Set is intended to be used for the calibration of the K-ASSAY CRP immunoturbidimetric assay for quantitating CRP in serum samples.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the K-ASSAY CRP Calibrator Set. This type of document does not contain the detailed information requested regarding acceptance criteria, study design, or performance metrics.

FDA 510(k) clearances primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trial data or performance studies as might be seen for devices seeking a de novo classification or PMA.

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

In general, for in vitro diagnostic (IVD) calibrator sets like the K-ASSAY CRP Calibrator Set, the acceptance criteria would typically relate to:

  • Accuracy: How well the calibrators provide known concentrations of the analyte (CRP)
  • Precision/Reproducibility: Consistency of the calibrator values across different lots, users, and instruments.
  • Stability: How long the calibrators maintain their assigned values under specific storage conditions.
  • Interference: Lack of interference from common substances found in serum.
  • Traceability: Often, calibrators are traceable to international reference materials or certified reference materials.

If a study were conducted, it would likely involve:

  • Measuring calibrator values using a validated reference method or the intended immunoturbidimetric assay.
  • Comparing results to target values or established reference ranges.
  • Testing different lots of calibrators and perhaps different instruments or operators.

However, none of this specific information is present in the provided FDA clearance letter.

§ 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).