(169 days)
Quantia IqE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunoglobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.
Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with Quantia Ferritin, Quantia Myoglobin and Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879 and also cleared for use with quantex Myoglobin K042982). For in vitro diagnostic use.
Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.
Quantia IgE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunodobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.
Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with the Quantia Ferritin, the Quantia Myoglobin and the Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin. reference K040879 and also cleared for use with quantex Myoglobin K042982) For in vitro diagnostic use.
Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.
Here's a breakdown of the acceptance criteria and the study information for the Quantia IgE device based on the provided text:
Acceptance Criteria and Reported Device Performance
The document implies acceptance criteria by demonstrating substantial equivalence to the predicate device. The key performance indicators used for this determination are related to method comparison and precision.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Method Comparison: Good correlation with predicate device (Quantia IgE vs. UniCAP Total IgE Fluoroimmunoassay) | Slope: 0.9650 |
| Correlation Coefficient (r): 0.9750 | |
| Precision (Within-run): Low Coefficient of Variation (CV) | CV at 47.3 IU/mL: 6.4 % |
| CV at 406.5 IU/mL: 0.7 % | |
| CV at 228.4 IU/mL (Control I + Control II): 1.0 % |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 101 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved evaluating IgE levels ranging from 10 to 2269 IU/mL. It is likely retrospective, comparing an existing set of samples against two different assays.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of in vitro diagnostic device study. The "ground truth" for the method comparison is the measurement obtained from the predicate device.
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Adjudication method for the test set:
- Not applicable. This is a quantitative assay comparison, not an interpretation-based study requiring adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device measuring a biomarker, not an imaging or interpretive AI system involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Quantia IgE assay (an algorithm in the sense of an automated test system) as it directly measures IgE levels and compares them to a predicate device without human intervention in the measurement process itself.
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The type of ground truth used:
- For the method comparison study, the measurement obtained from the UniCAP Total IgE Fluoroimmunoassay (K964152) was used as the reference or "ground truth" for comparison. The precision study used known control materials.
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The sample size for the training set:
- Not applicable as this is not a machine learning / AI model that requires a discrete training set. The "training" for such a system would involve the assay's development and optimization, which isn't described in terms of a specific data set size here.
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How the ground truth for the training set was established:
- Not applicable for the reason stated above.
§ 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).