K-ASSAY HS-CRP CONTROLS

• K Number: K022486
• Device Name: K-ASSAY HS-CRP CONTROLS
• Manufacturer: KAMIYA BIOMEDICAL CO.
• Date Cleared: 2002-08-14 ( 16 days)
• Product Code: DCK
• Regulation Number: 866.5270
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

The K-ASSAY® hs-CRP Control Set is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein immunoturbidimetric assays.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the K-ASSAY® hs-CRP Controls. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot fulfill your request for the information outlined. This type of detail is typically found in the 510(k) submission itself or in a separate summary document provided by the manufacturer, not in the 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).