K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

• K Number: K023828
• Device Name: K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
• Manufacturer: KAMIYA BIOMEDICAL CO.
• Date Cleared: 2003-02-04 ( 78 days)
• Product Code: DCK
• Regulation Number: 866.5270
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended Use

The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.

The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "K-Assay® CRP (3)". This document primarily addresses the substantial equivalence of the device and its intended use. It does not contain the specific information required to answer the questions about acceptance criteria and the study that proves the device meets those criteria.

The document states the device's indications for use: "The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases."

To answer your detailed questions about acceptance criteria and studies, a different type of document, such as the full 510(k) submission summary or a scientific study report, would be needed. These documents typically outline analytical and clinical performance studies, their methodologies, and results against defined acceptance criteria.

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

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).