FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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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.

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K Number

K011079

Device Name

K-ASSAY HS-CRP CONTROLS

Manufacturer

KAMIYA BIOMEDICAL CO.

Date Cleared

2001-05-16

(37 days)

Product Code