JAS CARBON DIOXIDE LIQUID REAGENT

• K Number: K012332
• Device Name: JAS CARBON DIOXIDE LIQUID REAGENT
• Manufacturer: JAS Diagnostics, Inc.
• Date Cleared: 2001-09-06 ( 45 days)
• Product Code: KHS
• Regulation Number: 862.1160
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.

Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Carbon Dioxide Liquid Reagent. This document approves the device but does not contain the acceptance criteria or the study details that prove the device meets those criteria.

Therefore, I cannot provide the requested information based on the given text. The text only confirms the device's classification and allows its marketing based on substantial equivalence to a predicate device, but it does not detail the performance study findings or acceptance criteria.

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.