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NPT7 Series pH/Blood Gas and Co-oximetry System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982928

by Radiometer America, Inc.

Identifiers

510(k) Number
K982928 FDA 510(k)
FDA Product Code
CHL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1120 FDA 510(k)
Regulation Number
862.1120 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NPT7 Series pH/Blood Gas and Co-oximetry System is an electrode measurement device for blood gases (pCO2, pO2) and blood pH, classified under the Clinical Chemistry specialty. It is designed for the measurement of pH, blood gases, and co-oximetry parameters in whole blood samples.

The system is intended for use in laboratory and point-of-care testing by minimally trained personnel. It received FDA 510(k) clearance (K982928) as substantially equivalent, with regulation number 862.1120 and product code CHL.

Frequently asked questions

What types of measurements can the NPT7 Series system perform, and is it suitable for both laboratory and point-of-care testing?

The NPT7 Series is designed to measure pH, blood gases (pCO₂ and pO₂), and co-oximetry parameters in whole blood samples. It is explicitly intended for use in both laboratory and point-of-care settings, allowing minimally trained personnel to perform these tests efficiently.

Is the NPT7 Series system single-use or reusable, and how should it be handled after use?

The NPT7 Series is not described as single-use or reusable in the provided data, but it is an electrode measurement device intended for blood gas and co-oximetry testing. Proper cleaning, maintenance, and sterilization protocols (if applicable) should follow the manufacturer’s instructions to ensure accurate and reliable results.

What regulatory pathway was followed for FDA clearance of the NPT7 Series, and what classification does it fall under?

The NPT7 Series received FDA 510(k) clearance under the Traditional pathway, classified as substantially equivalent (SESE) to a predicate device. It falls under the Clinical Chemistry specialty (product code CHL) and regulation number 862.1120, indicating its intended use in chemical analysis of blood samples.

Are there multiple models or configurations of the NPT7 Series, and if so, how are they differentiated?

The provided data lists multiple registration numbers (e.g., 3005643513, 3014506106) under the NPT7 Series, suggesting there may be variations or different configurations. However, specific differences between models (e.g., features, sizes, or technical specifications) are not detailed in the data. Contacting Radiometer America, Inc. would clarify any model-specific distinctions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (K982928) — FDA 510(k ..., NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM… - FDA.report, PDF K982928 - Npt7 Series Ph/Blood Gas and Co-oximetry System, www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Radiometer America, Inc.

Sources (1)

  • FDA 510(k) K982928 24 fields · synced Oct 6, 2026