STAT PROFILE PHOX PLUS L ANALYZER

• K Number: K012058
• Device Name: STAT PROFILE PHOX PLUS L ANALYZER
• Manufacturer: NOVA BIOMEDICAL CORP.
• Date Cleared: 2001-08-20 ( 49 days)
• Product Code: CHL , CEM , CGA , CGZ , GKR , JFP , JGS , JIP , JIX
• Regulation Number: 862.1120
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-(or Ca++), Glu and Lac in heparinized whole blood.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the "Stat Profile pHOx Plus L Analyzer" and does not contain the detailed study information required to answer the prompt thoroughly. The letter confirms substantial equivalence to a predicate device and allows marketing, but it does not include the acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details of a comparative effectiveness study.

Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document is a regulatory approval, not a scientific study report.

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.