(133 days)
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Lac and Creat in heparinized whole blood, and Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Lac and Creat in serum and plasma.
Not Found
The provided document is a 510(k) premarket notification letter for the Stat Profile Critical Care Xpress Analyzer. It outlines the device's indications for use and states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria, beyond the general statement of substantial equivalence.
Therefore, I cannot directly extract the specific acceptance criteria and detailed study information as requested.
However, I can interpret what would typically be expected for a device like this based on the document's content and general FDA regulatory requirements for in vitro diagnostic devices.
Based on the typical requirements for devices like the Stat Profile Critical Care Xpress Analyzer, and the provided document's limited information, here's what can be inferred or generally expected for such a submission:
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which means demonstrating that the new device is as safe and effective as a legally marketed device. This typically involves performance data, but the specifics are not included in this letter.
Hypothetical Acceptance Criteria and Study Information (Based on typical performance studies for similar IVDs, NOT explicitly stated in the document):
Given that this is an in vitro diagnostic (IVD) device for measuring various analytes in blood, serum, and plasma, the acceptance criteria would typically revolve around:
- Accuracy/Bias: How close the device's measurements are to a reference method or true value.
- Precision/Reproducibility: How consistent the device's measurements are when repeated under similar conditions.
- Linearity/Measuring Range: The range over which the device can accurately measure the analytes.
- Interference: How various substances in the sample (e.g., hemolysis, lipemia, common medications) affect the measurements.
- Sample Matrix Equivalency: Ensuring comparable performance across different stated sample types (whole blood, serum, plasma).
Disclaimer: The following table and sections contain assumed information based on general IVD performance claims, as the specific data is not present in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter (Analyte) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| pH | Bias ≤ ±0.02 pH units (vs. reference) | Bias: ±0.015 pH units |
| pCO2 | Bias ≤ ±2 mmHg or 5% (whichever is greater) | Bias: ±1.5 mmHg |
| pO2 | Bias ≤ ±3 mmHg or 5% (whichever is greater) | Bias: ±2.0 mmHg |
| Na+ | Bias ≤ ±2.0 mmol/L or 2% (whichever is greater) | Bias: ±1.5 mmol/L |
| K+ | Bias ≤ ±0.15 mmol/L or 4% (whichever is greater) | Bias: ±0.10 mmol/L |
| Cl- | Bias ≤ ±2.0 mmol/L or 2% (whichever is greater) | Bias: ±1.8 mmol/L |
| Glucose | Bias ≤ ±6 mg/dL or 10% (whichever is greater) | Bias: ±5 mg/dL |
| Precision (CV%) | ≤ 2.0% for most analytes at medical decision levels |
§ 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.