(18 days)
The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb, SulfHb and metabolites; glucose, lactate and urea nitrogen in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.
The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 17 tests per sample.
Here's a breakdown of the acceptance criteria and study information for the AVL OMNI™ Modular Analyzer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it implicitly defines acceptance through the concept of "substantial equivalence" to predicate devices and the demonstration of "no significant difference in mean values" and "correlation" during clinical trials. The "reported device performance" is largely described qualitatively.
| Parameter/Test | Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|---|
| Substantial Equivalence | The device should be substantially equivalent in function, safety, and efficacy to specific legally marketed predicate devices. | Stated as substantially equivalent to "Combi Analyzers" and specifically for Urea Nitrogen to NOVA Biomedical ULTRA H [K960120] and i-STAT 200 Portable Clinical Analyzer (K940918). |
| Precision | Demonstrated acceptable "Within-Run (S_wr), Between-Day (S_dd) and Total (S_T) precision." (No numerical thresholds provided). | "Typical Within-Run (S_wr), Between-Day (S_dd) and Total (S_T) precision were evaluated" for all assays. The conclusion statement implies the precision was found acceptable. |
| Linearity in Aqueous Solutions | Demonstrated linearity across a known range of values. (No numerical thresholds provided). | Aqueous standard solutions measured on three AVL OMNI™ units demonstrated linearity. The conclusion statement implies the linearity was found acceptable. |
| Linearity in Serum | Demonstrated linearity by diluting patient-sample pools. (No numerical thresholds provided). | Patient-sample pools diluted and measured on two AVL OMNI™ instruments demonstrated linearity. The conclusion statement implies the linearity was found acceptable. |
| Interferences | No significant effects on measurement from various analytes or drugs. (No numerical thresholds provided). | "No significant effects on measurement were demonstrated at the concentrations evaluated" for urea nitrogen. |
| Clinical Correlation | No significant difference in mean values (P |
§ 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.