(301 days)
The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).
The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.
The Sanguina AnemoCheck device is a semi-quantitative colorimetric assay for determining total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood.
Here's an analysis of its acceptance criteria and supporting study information:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates "substantial equivalence based on accuracy and precision" relative to the predicate device. For a semi-quantitative device measuring hemoglobin, typical acceptance criteria would involve a certain level of agreement or correlation with a reference method, often expressed as a percentage of agreement within a clinically acceptable range or a specific mean difference and standard deviation.
The document states:
- "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision."
- "Test results are comparable to other test methods in clinical laboratory and point-of-care practices."
Without specific numerical targets for accuracy (e.g., within X% of a reference method) or precision (e.g., coefficient of variation below Y%), the exact "acceptance criteria" are not fully detailed. The conclusion of "substantial equivalence" implies that the performance met the FDA's criteria for a device of this type, likely benchmarked against predicate devices like the Hemocue® Hemoglobin Hb 201+ Analyzing System and Siemens® Advia 2120i.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the sample size used for the test set in the "Summary of Non-clinical Testing" or "Assessment of Performance" sections.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts and their Qualifications for Ground Truth
- The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. Given that it's an in vitro diagnostic device for hemoglobin measurement, the "ground truth" would typically be established by a laboratory reference method (e.g., a hematology analyzer) rather than expert consensus, though interpretation of results might involve medical professionals.
4. Adjudication Method
- The document does not describe any adjudication method. This is expected given that the ground truth for an IVD device like this would likely be an objective measurement from a reference instrument, not subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for interpretative devices where human readers assess medical images or data. The AnemoCheck is a direct measurement device, not an interpretative one in the context of MRMC studies.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone study was performed. The "Summary of Non-clinical Testing" states: "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision." This implies the device's performance was evaluated inherently, as a semi-quantitative colorimetric assay, without human interpretation as part of the core measurement. The output of the device (color change) is interpreted manually to determine the hemoglobin level, making it a "manual test that does not require electrical power or additional equipment."
7. Type of Ground Truth Used
- The type of ground truth used would be objective laboratory measurements from predicate or reference devices. The text states: "Bench testing of AnemoCheck versus the predicate device..." and "Test results are comparable to other test methods in clinical laboratory and point-of-care practices." This strongly indicates the AnemoCheck's measurements were compared against established, quantitative hemoglobin assays (like the Hemocue Hb 201+ or Siemens Advia 2120i) which serve as the ground truth.
8. Sample Size for the Training Set
- The document does not explicitly state the sample size used for any training set. As a manual, semi-quantitative colorimetric assay, the development process might involve calibration and optimization rather than a "training set" in the machine learning sense. The information provided focuses on the validation of the final device.
9. How Ground Truth for the Training Set Was Established
- The document does not provide information on how ground truth was established for any training set. If a training phase existed (e.g., for optimizing the color scale), it would logically also rely on objective laboratory measurements from reference methods for hemoglobin.
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.