(55 days)
The BioCheck IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA)
The provided text is a 510(k) clearance letter from the FDA for the BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA). This document primarily focuses on regulatory approval and does not contain the detailed study information typically found in a clinical study report or a scientific publication.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone performance) is not available in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in this document. The FDA letter states the device is "substantially equivalent" to legally marketed predicate devices, implying it meets established performance characteristics, but the specific criteria are not listed.
- Reported Device Performance: Not included in this regulatory letter. This information would typically be in a separate study report submitted to the FDA as part of the 510(k) application.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/available. This device is an in vitro diagnostic (IVD) test kit, not an imaging AI device that typically relies on expert interpretation for ground truth. The "ground truth" for an IVD kit would likely be established through reference methods or clinical diagnosis, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/available. Adjudication methods like 2+1 are typically used in studies involving human interpretation (e.g., radiology readers) where there might be disagreement. For an IVD kit, performance is usually assessed against a reference standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are used for evaluating AI-assisted human performance, primarily in imaging. This device is an immunoassay test kit, which is a standalone diagnostic test performed in a lab, not an AI assisting a human reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. As an in vitro diagnostic test kit, the BioCheck IgE ELISA operates as a standalone diagnostic tool. Its performance (e.g., sensitivity, specificity, accuracy, precision, linearity) would have been assessed independently. However, the details of such a standalone performance study are not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For an IgE assay, the ground truth would likely be established through:
- Clinical diagnosis of hypersensitive/allergic reactions: Based on patient history, symptoms, other diagnostic tests, and potentially positive responses to allergy testing (e.g., skin prick tests, challenge tests).
- Reference methods: Comparison to a legally marketed predicate device or a well-established laboratory method for IgE quantification.
- Not explicitly stated in the provided text.
8. The sample size for the training set
- Not applicable/available. This device is a chemical immunoassay kit, not an AI algorithm that requires a "training set" in the machine learning sense. Its development would involve analytical and clinical validation studies, but not a training set.
9. How the ground truth for the training set was established
- Not applicable/available for the same reasons as point 8.
In summary, the provided FDA 510(k) clearance letter confirms the device's regulatory approval as "substantially equivalent" but does not contain the detailed technical and clinical study data requested. That information would be found in the applicant's 510(k) submission, specifically in the performance data sections.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).