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K Number
K023567
Device Name
STAT PROFILE PHOX PLUS L ANALYZER
Manufacturer
NOVA BIOMEDICAL CORP.
Date Cleared
2002-12-20

(58 days)

Product Code
CHL,CEM,CGZ,GJS,GKR,JFP,JIX,JKS,JPI,JPK,KHP
Regulation Number
862.1120
Type
Abbreviated
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "Stat Profile pHOx Plus L. Analyzer". This document indicates the device has been found substantially equivalent to a predicate device for its stated indications for use.

However, this letter does NOT contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on the regulatory approval process, confirming that the device can be marketed in the US. It does not include the technical study reports that would detail the performance data and the methods used to generate that data.

To answer your questions, one would typically need access to:

  • The actual 510(k) submission document, specifically the sections dealing with performance testing.
  • Validation reports from Nova Biomedical for the Stat Profile pHOx Plus L. Analyzer.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner you've requested. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case comparative effectiveness study information.
  6. Standalone performance information.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.