RDI HS CRP KIT

• K Number: K021609
• Device Name: RDI HS CRP KIT
• Manufacturer: REFERENCE DIAGNOSTICS, INC.
• Date Cleared: 2002-06-27 ( 42 days)
• Product Code: DCK
• Regulation Number: 866.5270
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

For in vitro diagnostic use only. The RDI hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.

Device Description

Not Found

AI/ML Overview

This letter from the FDA is a clearance letter for a medical device called the "RDI hs CRP Kit (C-reactive protein)". It states the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the 510(k) submission document itself, which is not provided here.

Therefore, I cannot fulfill your request for the table and study details based on the provided text. The document only confirms the FDA's decision to clear the device for marketing.

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).