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510(k) Data Aggregation
(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.
Not Found
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.
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(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 |
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