N-ASSAY TIA MULTI CRP CALIBRATOR SET

• K Number: K965110
• Device Name: N-ASSAY TIA MULTI CRP CALIBRATOR SET
• Manufacturer: CRESTAT DIAGNOSTICS, INC.
• Date Cleared: 1997-07-03 ( 195 days)
• Product Code: DCK
• Regulation Number: 866.5270
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The N-Assay TIA Multi CRP CAlibrator Set is intended to be used in the calibration of the Crestat Diagnostics N-Assay TIAGRP turbidimmunometric assay for quantitating serum levels of C-Reactive Protein. in human serum.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA letter (K965110/S001 for N-Assay® TIA MULTI C-Reactive Protein Calibrator Set) does not contain the information required to answer your request.

The letter is a notification of substantial equivalence for a medical device (a calibrator set for an assay). It outlines regulatory compliance and allows the device to be marketed. However, it does not describe:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria (including all the specified details like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.).

This type of information would typically be found in the 510(k) submission document itself, which is not provided, or a separate study report. The letter is a regulatory approval, not a scientific study summary.

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).