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K Number
K982928
Device Name
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
Manufacturer
RADIOMETER AMERICA, INC.
Date Cleared
1999-01-06

(139 days)

Product Code
CHL,CEM,CGA,CGZ,GKF,JGS,JHP,KHP
Regulation Number
862.1120
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO2 pO2 ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.

Device Description

NPT7 Series is a stand-alone blood gas analyzer

AI/ML Overview

This FDA 510(k) clearance letter dated January 6, 1999, for the Radiometer America Inc. NPT7 Series Analyzer with DRI-TEK Cartridge, does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory aspects such as:

  • Trade Name: NPT7 Series Analyzer with DRI-TEK Cartridge
  • Product Codes and Regulatory Classifications: CHL, JHP, CGA, CGZ, CEM, JGS, & GKF (Class II), KHP (Class I)
  • Date Received and Dated: August 12, 1998, and August 20, 1998
  • Substantial Equivalence Determination: Based on its comparison to predicate devices marketed before May 28, 1976.
  • General Controls Provisions of the Act: Mentioning annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
  • Contact Information for Further Assistance: Regarding labeling, promotion/advertising, and general responsibilities.
  • Indications for Use: Measures pH, pCO2, pO2, and Co-oximetry parameters on human arterial/venous and capillary whole blood, intended for use in laboratory and point-of-care testing by minimally trained personnel, and designed for stationary use as well as in moving vehicles and aircraft.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

§ 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.