(358 days)
Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only.
epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.
Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit.
Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System.
Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box.
The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html
The provided text describes a 510(k) submission for "Eurotrol Hct Control and epoc® Hematocrit Verification Fluids," which are quality control materials for hematocrit measurements. This document is a premarket notification for a medical device that verifies the precision and accuracy of another device (the epoc Blood Analysis System). It is not a diagnostic device that performs a clinical diagnosis; thus, the concepts of sensitivity, specificity, human reader performance, MRMC studies, or training/test sets for AI models as typically applied to image-based diagnostic AI devices are not applicable here.
The "acceptance criteria" and "device performance" in this context refer to the characteristics and performance of the control fluid itself in demonstrating its suitability for verifying other devices.
Here's the breakdown based on the provided text, adapted for a quality control material:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a quality control material revolve around its ability to provide stable and accurate reference values. The "performance" is demonstrated by its inherent properties and its equivalence to a predicate device.
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (New Device) |
|---|---|---|
| Number of Levels | Must have multiple levels to cover clinically significant ranges (Predicate has 5) | 5 distinct Hct levels (conductivity), simulating clinically significant ranges of Hematocrit. |
| Analytes | Hematocrit (Conductivity) | Hematocrit (Conductivity) |
| Container | Suitable for stability and handling (Predicate: Clear glass ampules) | Clear glass ampules |
| Filling Volume | Sufficient for use (Predicate: 1.7 mL) | 2.5 mL |
| Color | Clear, to avoid interference | Clear |
| Storage Temperature | Stable within a reasonable range (Predicate: 2 - 25°C/35 - 77°F) | 2 - 30°C/35 - 86°F (Broader, which is an improvement) |
| Matrix/Materials | Stable aqueous solution without interfering substances | Prepared using pure chemicals in a physiologically buffered matrix. Aqueous buffered solution of water and electrolytes. This product contains no red cells and no human or biological materials. |
| Intended Use | To verify precision and accuracy of hematocrit measurement systems | To verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. |
| Stability | Must maintain performance over time | 12 months (Real-time evaluation of the products to support stability was conducted.) |
| Precision (QC fluid) | The QC fluid itself should provide consistent results | Precision testing was conducted. (Specific values for precision are not provided in the summary but were generated for the submission). |
| Accuracy (QC fluid) | The QC fluid should have assigned values that laboratories can use for reference | Assigned values of each batch are printed on a value sheet as available from the Epocal website (http://www.epocal.com/doc_library.html). (This demonstrates how users verify accuracy of their instrument against the QC fluid's known value.) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the typical sense of a diagnostic device's test set for patient data. For this quality control material, the "test set" would refer to the samples of the QC fluid itself tested during its development and validation.
- Test Samples: The document states "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of the products to support stability. b) Test precision." The exact number of ampules or batches tested for these purposes is not specified in the summary but would have been part of the non-clinical testing data submitted to the FDA.
- Data Provenance: The testing was conducted by Eurotrol B.V. in The Netherlands. This is a non-clinical, controlled laboratory setting, not patient data. It is inherently prospective testing of the manufactured QC material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for a quality control material is established by:
- Its chemical formulation.
- The highly precise and accurate methods used to assign values to each lot/batch in a reference laboratory setting (e.g., using reference methods and highly calibrated instruments).
- Comparative testing against established predicate devices.
There are no "experts" in the sense of clinical reviewers establishing diagnoses as ground truth for this type of device.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or diagnostic decision-making involved that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially in the context of AI assistance. A quality control material does not involve human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a fluid, not an algorithm. Its "performance" is its chemical stability and its ability to act as a reliable reference standard for an analytical instrument.
7. The Type of Ground Truth Used
The ground truth for this quality control material is its precisely manufactured and characterized chemical composition and its assigned hematocrit values, which are determined by highly accurate reference measurement procedures. This is essentially a "reference standard" or "master value" derived from rigorous chemical and metrological characterization. Its primary evidence for substantial equivalence relies on comparison to a predicate device (RNA Medical QC 900 Hematocrit Control) that is already legally marketed and accepted as a reliable standard.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require training sets of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.