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510(k) Data Aggregation
(183 days)
The Quantikine IVD β,-microglobulin EIA kit is intended for the quantitative determination of β, microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.
The product is a competitive binding enzyme immunoassay (EIA) for ß2 microglobulin.
The provided text describes the acceptance criteria and performance of the Quantikine™ IVD™ ß2 microglobulin enzyme immunoassay.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Signal generated by standard 0 to be greater than 1.5 absorbance units | Not explicitly stated, but implied to be met for device approval. |
| Signal generated by standard 5 to be less than 0.35 absorbance units | Not explicitly stated, but implied to be met for device approval. |
| Curve fitting individual replicates of Standard 1 to fit within ±15% of nominal value and the Mean value of Standard 1 to fit within ±10% of nominal value. Individual replicates and Mean values of Standards 2-5 to fit within ± 10% of nominal value. | Not explicitly stated, but implied to be met for device approval. |
| In-house control and kit control values to be within the ranges quoted on the appropriate control data sheets. | Not explicitly stated, but implied to be met for device approval. |
| Sensitivity to be less than 0.2 µg/mL. | < 0.2 µg/mL |
| Precision (based on 10 replicates of three in-house controls) to be typically less than 8%. | Typically < 8% |
| Additional Performance Attributes: | |
| Accuracy | Demonstrated acceptable performance (no specific values provided) |
| Precision (general) | Demonstrated acceptable performance (specific precision above) |
| Stability (Expiration dating) | 26 weeks when stored at 2-8°C |
| Stability (Opened/diluted reagents) | Up to 4 weeks when stored at 2-8°C (within expiration date) |
| Other performance parameters | Similar to the predicate device (Pharmacia's B2 Micro RIA) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The nonclinical testing "centered on the performance attributes of accuracy, precision and stability." For precision, "10 replicates of three in-house controls" were used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is an immunoassay device, not an imaging or diagnostic device that typically relies on expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in the context of radiologists for imaging is not applicable here. The ground truth for this type of device would be based on established analytical methods and reference standards for calibrating the assay and determining analyte concentrations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for an immunoassay device. Adjudication methods are typically used in studies where human readers or interpreters are involved in determining ground truth or evaluating performance, such as in clinical trials or diagnostic imaging studies.
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
No, this is not applicable. The device is an immunoassay, a laboratory test for directly measuring a biomarker (β2 microglobulin). It does not involve human readers interpreting images or data that would be augmented by AI, nor is it an AI-powered diagnostic tool itself.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance described is a standalone performance of the immunoassay kit itself. As an in vitro diagnostic (IVD) device, its performance characteristics (accuracy, precision, sensitivity, stability) are determined by testing the kit's ability to measure β2 microglobulin concentrations directly, without human interpretation as part of its primary function beyond following the assay protocol. The "algorithm" here refers to the biochemical reactions and detection mechanism of the EIA.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an immunoassay, the "ground truth" for analytical performance (accuracy, precision, sensitivity) would typically be established using:
- Reference materials/standards: Known concentrations of β2 microglobulin used for calibration and validation.
- Spiked samples: Samples with a known, added amount of analyte to assess recovery.
- Established analytical methods: Comparison against a gold standard or a well-validated reference method.
The document does not explicitly detail the ground truth method but implies the use of "standards" (Standard 0 to 5) and "in-house controls," which are fundamental to establishing ground truth in immunoassay validation.
8. The sample size for the training set
The concept of a "training set" in the machine learning sense is not applicable to this traditional immunoassay. These devices are developed based on established biochemical principles (competitive binding immunoassay) rather than being "trained" on a dataset like an AI algorithm. Their performance is validated through analytical studies.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/machine learning model for this traditional immunoassay.
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