Search Results

The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.

The FastPack® Free T4 Immunoassay is a competitive chemiluminescense assay.
● Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 10 seconds at 37° C.

• . Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37° C.
• . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
• . Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C.

The provided text describes the FastPack® Free T4 Immunoassay on the FastPack® Analyzer System. Here's a breakdown of the acceptance criteria and the study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's performance characteristics in a tabular format. Instead, it presents the performance data of the FastPack® Free T4 Immunoassay and compares it directly to a predicate device (Abbott IMx® Free T4). The implication is that the performance shown met the internal criteria or was considered substantially equivalent to the predicate device.

Here's a table summarizing the reported device performance, with the predicate device's performance for comparison, which implicitly sets a benchmark for acceptance:

Note: The acceptance criteria for the FastPack® device are implicitly demonstrated by its performance being comparable or superior to the predicate device in key metrics, as required for 510(k) clearance based on substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size for Method Comparison: n = 131 samples were used for the method comparison study against the Abbott IMx Free T4.
• Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It is implied to be clinical samples used for assay validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to this type of device. The ground truth for an immunoassay like this is established by the reference method (in this case, the predicate device Abbott IMx Free T4) and other analytical validation methods (precision, sensitivity, interference). It does not involve human expert interpretation of images or other subjective data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable to this type of device. Adjudication methods are typically used when there are subjective interpretations being made by humans (e.g., in medical image analysis). For an in vitro diagnostic immunoassay, the "adjudication" is inherent in the analytical process and result generation, verified against established analytical standards and predicate device performance.

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 information is not applicable to this type of device. An immunoassay is an automated analytical test, not an AI-assisted diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not applicable in the context of an AI algorithm. However, the FastPack® Free T4 Immunoassay itself is a standalone diagnostic test in the sense that the system provides a quantitative result without continuous human intervention in the result generation process once the sample is loaded and the test initiated. The performance characteristics described (precision, sensitivity, method comparison) are all "standalone" performance metrics of the device as an automated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth for this device's performance is established by:
  • Reference Intervals/Ranges: The stated assay range of 0.4 to 6 ng/dL for Free T4, which aligns with clinical understanding of normal/abnormal levels.
  • Comparison to a Legally Marketed Predicate Device: The Abbott IMx Free T4 system served as the primary comparative ground truth, with performance metrics (correlation coefficient, regression equation) indicating agreement.
  • Analytical Validation: Internal studies demonstrating precision, analytical sensitivity, and non-interference from common substances.

8. The sample size for the training set

• This information is not explicitly provided in the document. For an immunoassay, there isn't a "training set" in the machine learning sense. Instead, development and optimization would involve numerous samples during method development, reagent optimization, and calibration curve generation. The 131 samples mentioned were specifically for the method comparison study, which is part of validation.

9. How the ground truth for the training set was established

• As mentioned above, there isn't a "training set" in the AI sense. For an immunoassay, the "ground truth" for developing and calibrating the system would be established through a combination of:
  • Known concentration samples: Using gravimetrically prepared or independently validated samples with known Free T4 concentrations to develop the assay and establish its dose-response curve.
  • Reference methods: Comparing early versions of the assay to existing, validated laboratory reference methods.
  • Clinical samples: Using a large panel of clinical samples with clinically confirmed diagnoses or results from established methods to fine-tune the assay's performance and ensure accurate measurement across the intended analytical range.
  • Calibrators: The FastPack® Testo/Free T4 Calibrator is used to calibrate the system, implying that these calibrators have assigned values based on rigorous analytical standards, acting as a form of ground truth for instrument calibration.

Ask a specific question about this device