(105 days)
The AnemiaPro™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.
The device is a kit containing the materials necessary to self-collect and test a capillary blood sample using a single-use, disposable unit. The test unit is a self-contained plastic housing for a nitrocellulose-based test strip, which employs the principals of blood cell separation. The plasma that is obtained during blood separation migrates through the test strip, and the migration front is made visible by staining with an impregnated dye. The plasma migration distance is linearly and inversely proportional to hemoglobin concentration. The kit is comprised of a blood testing unit packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, and collection instructions containing information about anemia.
Here's a breakdown of the acceptance criteria and study information for the AnemiaPro™ Self-Screener, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it does describe the performance studies conducted and what they aimed to evaluate. The results indicate that the device met the implicit criteria for substantial equivalence to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Precision (Consistency of results) | Studied as a performance characteristic. Specific quantitative results are not provided in this summary, but the context implies acceptable precision for substantial equivalence. |
| Linearity (Accuracy across a range of values) | Studied as a performance characteristic. Specific quantitative results are not provided in this summary, but the context implies acceptable linearity for substantial equivalence. |
| Analytical Accuracy (Closeness to true value) | Studied as a performance characteristic. Specific quantitative results for accuracy are not provided, but the statement "Results of clinical trials have shown that self-collected capillary samples correlate closely with paired venous whole blood samples tested with the aforementioned predicate devices" directly addresses this. |
| Correlation (Agreement with predicate devices) | "Results of clinical trials have shown that self-collected capillary samples correlate closely with paired venous whole blood samples tested with the aforementioned predicate devices [Cell Dyn 3700 Analyzer and HemoCue B-Hemoglobin Instrument]." This is a key finding demonstrating substantial equivalence. |
| Interference Effects (Resistance to interfering substances) | The AnemiaPro™ Self-Screener was evaluated for effects of interferences. The summary implies that any interference effects were within acceptable limits, though specific data is not provided. |
| Sample Environmental Factors (Stability under various conditions) | The AnemiaPro™ Self-Screener was evaluated for effects of sample environmental factors. The summary implies that the device performs acceptably under varying environmental factors, though specific data is not provided. |
| Substantial Equivalence to legally marketed predicate devices | Explicitly stated: "The AnemiaPro™ Self-Screener has technological characteristics that are substantially equivalent to that of the predicate devices listed above. The AnemiaPro™ Self-Screener provides components that permit self-collection and testing of a capillary blood sample for determination of hemoglobin Results of clinical trials have shown that self-collected capillary samples correlate closely with paired venous whole blood samples tested with the aforementioned predicate devices." |
Study Information
The document provides a summary of the performance studies.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a single number. The studies were conducted on "self-collected capillary blood samples from volunteer study subjects." The phrase "three different geographical trial sites" suggests a decent number of participants, but the exact number isn't provided in this summary.
- Data Provenance: Prospective. The studies involved "volunteer study subjects" from whom samples were "collected." Samples were collected from "three different geographical trial sites."
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- "A corresponding venous blood sample and a professionally collected capillary blood sample were collected by the health care professional in order to compare venous hemoglobin results to those obtained from both capillary blood samples tested on the Anemia Test Devices."
- The "health care professional" served as the primary expert for professional capillary blood sample collection.
- "Venous samples were express shipped to BIOSAFE Laboratories for hemoglobin analysis using the predicate methods." This implies that the predicate devices' results, performed by qualified laboratory personnel at BIOSAFE Laboratories, served as the ground truth. The specific number and qualifications of these laboratory personnel are not provided.
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Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for conflicting results. The comparison was made between the AnemiaPro™ device, professionally collected capillary samples, and venous blood samples tested on predicate devices. It seems the predicate device results served as the reference standard.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers assisting with the device's output and measuring their improvement was not conducted or described. This device is an in vitro diagnostic (IVD) for determining hemoglobin concentration, not an imaging or diagnostic aid for human interpretation.
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Standalone (Algorithm Only) Performance:
- Yes, the performance study effectively evaluates the standalone performance of the AnemiaPro™ Self-Screener. The device provides "determination of hemoglobin concentration," which is a direct output. Its performance was compared against predicate devices, indicating its standalone accuracy.
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Type of Ground Truth Used:
- The primary ground truth appears to be comparison with predicate devices (Cell Dyn 3700 Analyzer and HemoCue B-Hemoglobin Instrument) using venous blood samples, which are generally considered a gold standard for hemoglobin measurement in a clinical setting. Professionally collected capillary blood samples also served as a comparative reference.
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Sample Size for the Training Set:
- The document does not mention a separate training set or its sample size. The description focuses on "performance studies" and "clinical trials" which are typically used for validation. For a device like this, the 'training' often refers to assay development and optimization, rather than a machine learning training set as in AI.
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How the Ground Truth for the Training Set Was Established:
- Since a separate "training set" in the context of machine learning or complex algorithms is not described, the method for establishing ground truth for such a set is not applicable or provided in this summary. The fundamental accuracy and comparison were based on the predicate devices during the performance studies.
§ 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.