(71 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.
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 device modification is to revise the limitations statement to allow testing of the whole blood sample for up to 30 days following collection. Currently the limitations states 10 days. No changes to the kit components.
The provided document describes a 510(k) premarket notification for a modification to the MyAllergyTest® device. The modification is to extend the allowable time for a whole blood sample to be tested from 10 days to 30 days after collection.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported (Implied) Device Performance |
|---|---|
| Maintain "accurate assessment of allergen specific IgE" for 30 days. | "The results from these studies (Initial testing and validation results) confirmed that the sample would be stable during the indicated transport time [30 days]." |
Note: The document does not explicitly state numerical acceptance criteria (e.g., specific percentage agreement or correlation thresholds). The acceptance criterion is implied by the need to ensure an "accurate assessment" of IgE levels after 30 days.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the stability studies (test set). It also doesn't indicate the country of origin of the data or whether the study was 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 information is not provided. The study appears to be about sample stability for laboratory testing, not interpretation by human experts. The "ground truth" would likely be established by lab-based assay results, not expert consensus in the traditional sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study involves laboratory measurements for sample stability, not expert interpretation requiring adjudication.
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
This is not applicable. The device is a sample collection kit, and the study focuses on the stability of the collected sample, not on human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical sample collection kit, and the study evaluates the bio-chemical stability of the collected sample, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the stability studies would be the allergen specific IgE profile testing results obtained from the clinical laboratory at different time points (including 30 days) and compared against a baseline (e.g., immediate testing). The "accuracy" would be determined by comparing these results, likely through quantitative measures of IgE levels.
8. The sample size for the training set
This is not applicable. The study is a validation of sample stability, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device modification study.
Summary of the Study:
The study described is a "Blood Sample Stability Study." Its purpose was to "obtain 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 (30 days)." The study involved "Initial testing and validation results," which "confirmed that the sample would be stable during the indicated transport time." This implies a comparison of IgE levels from samples tested at baseline and after 30 days to ensure they remain consistent or within an acceptable variation range, thereby maintaining the accuracy of the overall allergen-specific IgE assessment. The specific methodologies and statistical analysis are not detailed in this document but are referred to in "Attachment (s) B and C."
§ 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.