SIGMA DIAGNOSTICS CO2 ACID REAGENT

• K Number: K963541
• Device Name: SIGMA DIAGNOSTICS CO2 ACID REAGENT
• Manufacturer: SIGMA DIAGNOSTICS, INC.
• Date Cleared: 1996-10-24 ( 50 days)
• Product Code: JFL
• Regulation Number: 862.1160
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: K963541

Intended Use

Used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.

Device Description

CO2 Acid Reagent, Procedure Number C7558

AI/ML Overview

This document is a 510(k) Notification for a diagnostic medical device, specifically the Sigma Diagnostics CX®3 CO2 Acid Reagent. It is not based on AI/ML; it's a traditional chemical reagent for measuring carbon dioxide. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable to this type of device and study.

However, I can extract the information relevant to its performance and acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalency to predicate device	Correlation coefficient: 0.992
	Regression equation: y = 0.95x + 1.54
Within-run precision (Implied %CV target)	%CV

Regulation Number and Section

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.