(120 days)
The MyAllergyTest™ is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTest™ is intended for use with the MyAllergyTest™ System. The MyAllergyTest™ is intended for home use by the lay consumer (Over-the-Counter).
MyAllergyTest™ is a Sample Collection Kit containing the materials necessary to collect and mail a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing.
The provided text describes the MyAllergyTest™ and its 510(k) submission, primarily focusing on its intended use as a blood sample collection kit for home use. The studies performed are to demonstrate the kit's functionality and consumer usability, not the diagnostic performance of an AI algorithm. Therefore, many of the requested fields related to AI performance metrics, ground truth, and expert evaluation are not applicable to this device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Stability Studies | Assurance that the whole blood sample would still provide an accurate assessment of allergen specific IgE for the entire transport time indicated in the labeling (seven days). | "The results from these studies confirmed that the samples would be stable for the entire seven days." |
| Mailing Studies | Assurance that the whole blood samples would still provide an accurate assessment of allergen specific IgE if sent by US Mail. | "The results from these studies confirmed that the samples would be stable when shipped using US Mail." |
| Consumer Studies | Assurance that the general public would be able to obtain a blood sample by following the MyAllergyTest™ package insert. | "The results from these studies confirmed that the general public would be able to obtain a blood sample by following the MyAllergyTest™ package insert." |
| Consumer Comprehension Studies | Assurance that the general public would be able to read and understand the MyAllergyTest™ package insert. | "The results from these studies confirmed that the general public would be able to read and understand the MyAllergyTest™ package insert." |
| Readability Studies | Assurance that the MyAllergyTest™ package was written at a 7th grade reading level (based on NCCLS GP 14-A Labeling of Home-Use In Vitro Testing Products). The text specifies "70 grade reading level" but then reports "7th grade reading level" in the results, suggesting a minor typo in the criterion description or a direct application of the SMOG formula to determine the grade level. | "The results from the SMOG Readability Formula (NCCLS GP 14-A Labeling of Home-Use In Vitro Testing Products) confirmed that the MyAllergyTest™ package was written at a 7th grade reading level." (This meets the implicit 7th-grade criterion as intended by the 70 grade mention). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text does not specify the sample sizes used for any of the studies (Stability, Mailing, Consumer, Consumer Comprehension, Readability). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
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)
This is not applicable as the device is a sample collection kit, not an AI diagnostic tool. The "ground truth" for the studies listed is related to the physical stability of blood samples, the ability of lay users to follow instructions, and the readability of documentation, not expert interpretation of medical images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for reconciling discrepancies in expert ground truth assessment, which is not part of the described studies for this device.
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. The MyAllergyTest™ is a sample collection kit, not an AI system or software with a human-in-the-loop component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The MyAllergyTest™ is a physical medical device (sample collection kit), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these studies would be defined by objective measurements based on the study type:
- Stability Studies & Mailing Studies: The "ground truth" would be the actual concentration or integrity of allergen-specific IgE markers in the blood samples after various transport conditions and durations, as measured by a clinical laboratory.
- Consumer Studies: The "ground truth" would be the successful collection of a blood sample by the lay consumer, verified objectively (e.g., by the presence of a viable sample).
- Consumer Comprehension Studies: The "ground truth" would be the ability of lay consumers to correctly answer questions or demonstrate understanding of the package insert.
- Readability Studies: The "ground truth" would be the calculated reading level of the package insert using the SMOG Readability Formula.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.