(102 days)
The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.
Fluorescent immunoassay reagents.
The provided text describes a 510(k) premarket notification for the Alfa Biotech (UK) Ltd AuraFlex® FT3, an immunoassay for free triiodothyronine. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Correlation of 0.9 with an "Other FT3 assay," with the specific linear relationship: AuraFlex® FT3 = 0.93 * (Other FT3 assay) + 0.2 pg/ml (or 0.3 pmol/l). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 110 human serum samples.
- Data Provenance: Not explicitly stated, but the submission is from Alfa Biotech (UK) Ltd, suggesting the study may have been conducted in the UK or with UK-sourced samples. The data type is retrospective as it refers to a "comparison study" that was "conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The "ground truth" appears to be established by comparison to another existing FT3 assay, rather than expert consensus on individual samples.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study conducted was a comparison of a new immunoassay against an existing one, not a study involving human readers or AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone study of the device (immunoassay) performance. There is no mention of human-in-the-loop performance or AI.
7. The Type of Ground Truth Used
The ground truth was established by comparison to the results of an "Other FT3 assay." This implies a reference method or legally marketed predicate device.
8. The Sample Size for the Training Set
This information is not provided in the given text. The text describes a "comparison study" of 110 samples, likely representing the test set for performance evaluation. There's no mention of a separate training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its ground truth was established is not applicable/not provided.
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.