(95 days)
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2%, Hematocrit (Hct), Ca++, total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), and Oxygen capacity (02Cap) in heparinized whole blood; Nat, K+, C1-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.
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The provided document is a 510(k) clearance letter from the FDA for the "Stat Profile Critical Care Xpress Analyzer." This device performs quantitative determinations of various analytes in blood. The document details the device's indications for use and clinical utility for each analyte.
However, the letter does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: The document only lists the analytes and their clinical utility, not specific performance metrics or acceptance criteria for accuracy, precision, etc.
- Sample size used for the test set and the data provenance: There is no mention of study design, sample sizes for test sets, or data origin (e.g., country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and their qualifications: The document is a regulatory clearance letter, not a study report. It does not detail how ground truth was established for any performance testing.
- Adjudication method for the test set: No information on adjudication is present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: MRMC studies are typically for imaging devices with human interpretation components. This device is an in vitro diagnostic analyzer, and such studies are not applicable.
- If a standalone (algorithm only without human-in-the-loop performance) was done: This is an IVD analyzer; its performance is inherently "standalone" in its measurement function, but no specific performance data or study details are provided.
- The type of ground truth used: Given it's an IVD device, the "ground truth" would typically be established by a reference method or laboratory standard, but this is not discussed.
- The sample size for the training set: Training set information is relevant for machine learning algorithms. While the analyzer might use algorithms internally, this document doesn't detail any machine learning component or its training. However, if "training set" refers to calibration or method development, the information is not present.
- How the ground truth for the training set was established: See point 8.
Conclusion:
The provided FDA 510(k) clearance letter for the Stat Profile Critical Care Xpress Analyzer does not contain the detailed study results, acceptance criteria, or information about ground truth establishment for performance testing. This type of information would typically be found in the 510(k) submission summary or a separate clinical/technical study report, neither of which is part of the provided text. The letter primarily confirms substantial equivalence to a predicate device based on the information submitted by the manufacturer.
§ 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.