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K Number
K021713
Device Name
STAT PROFILE PHOX PLUS C ANALYZER
Manufacturer
NOVA BIOMEDICAL CORP.
Date Cleared
2002-07-25

(63 days)

Product Code
CHL,CEM,CGA,CGZ,GKR,JEP,JGS,JIX,JKS,JPI,JPK
Regulation Number
862.1120
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stat Profile pHOx Plus C 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-, Ca++, and Glu in heparinized whole blood.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Stat Profile pHOx Plus C Analyzer." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific details about acceptance criteria, study design, or performance data as typically found in a scientific study report or the original 510(k) submission.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and reported device performance: This information is not present.
  • Sample size used for the test set and data provenance: Not mentioned.
  • Number of experts used to establish ground truth and their qualifications: Not mentioned.
  • Adjudication method: Not mentioned.
  • MRMC comparative effectiveness study: Not mentioned.
  • Standalone performance: While the device is for quantitative determination (implying standalone measurement), specific performance metrics (accuracy, precision, linearity) typically associated with standalone testing are not detailed here. The letter only clarifies its intended use and substantial equivalence.
  • Type of ground truth used: Not mentioned.
  • Sample size for the training set: Not mentioned.
  • How the ground truth for the training set was established: Not mentioned.

What the document does tell us:

  • Device Name: Stat Profile pHOx Plus C Analyzer
  • Intended Use: 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-, Ca++, and Glu in heparinized whole blood.
  • Regulatory Status: Substantially equivalent to predicate devices, Class II.
  • Ground Truth (Implication): For this type of in-vitro diagnostic device, the "ground truth" for demonstrating substantial equivalence typically involves comparing the device's measurements against established reference methods or predicate devices using patient samples or control materials. However, the specifics of how this was done are not in this letter.

To obtain the detailed information you requested, you would need to access the full 510(k) submission (K021713) itself, which would contain the study reports and data. The FDA clearance letter only summarizes the outcome of their review, not the detailed evidence presented.

§ 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.