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510(k) Data Aggregation
(61 days)
System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.
For in vitro diagnostic use.
In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA antibodies to yield insoluble aggregates.
Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Olympus IgA Reagent (OSR6X171):
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Olympus IgA (OSR6X171) reagent) |
|---|---|---|
| Precision (Total CV%) | ||
| AU400/400e Sample 1 | As good as or better than 1.53% | 2.43% |
| AU400/400e Sample 2 | As good as or better than 1.63% | 2.52% |
| AU400/400e Sample 3 | As good as or better than 1.26% | 2.95% |
| AU600/640/640e Sample 1 | As good as or better than 1.38% | 3.39% |
| AU600/640/640e Sample 2 | As good as or better than 1.08% | 3.85% |
| AU600/640/640e Sample 3 | As good as or better than 1.81% | 4.01% |
| AU2700/5400 Sample 1 | As good as or better than 2.64% | 1.50% |
| AU2700/5400 Sample 2 | As good as or better than 2.05% | 1.91% |
| AU2700/5400 Sample 3 | As good as or better than 3.29% | 1.83% |
| Assay Range | 10 to 700 mg/dL | 10 to 700 mg/dL |
| LoQ | Not specified (or comparable to predicate) | 10 mg/dL |
| Method Comparison (Linear Regression) | ||
| Intercept | Comparable to 1.3 mg/dL | 15.1 mg/dL |
| Slope | Comparable to 0.957 | 0.923 |
| R^2 | Comparable to 0.99 | 0.999 |
| N | Comparable to 94 | 111 |
| Range | Comparable to 54-660 mg/dL | 38-672 mg/dL |
| Interfering Substances | ||
| Bilirubin (AU400/400e) | Interference < 2% up to 40 mg/dL | Interference < 2% up to 40 mg/dL |
| Hemolysate (AU400/400e) | Interference < 2% up to 500 mg/dL | Interference < 1% up to 500 mg/dL |
| Lipemia (AU400/400e) | Interference < 10% up to 600 mg/dL | Interference < 10% up to 1000 mg/dL |
| RF (AU400/400e) | Not specified | Interference < 8% up to 600 IU/mL |
| Bilirubin (AU600/640/640e) | Interference < 5% up to 40 mg/dL | Interference < 3% up to 40 mg/dL |
| Hemolysate (AU600/640/640e) | Interference < 2% up to 500 mg/dL | Interference < 5% up to 500 mg/dL |
| Lipemia (AU600/640/640e) | Interference < 7% up to 1000 mg/dL | Interference < 6% up to 1000 mg/dL |
| RF (AU600/640/640e) | Not specified | Interference < 8% up to 600 IU/mL |
| Bilirubin (AU2700/5400) | Interference < 5% up to 40 mg/dL | Interference < 3% up to 40 mg/dL |
| Hemolysate (AU2700/5400) | Interference < 3% up to 500 mg/dL | Interference < 4% up to 500 mg/dL |
| Lipemia (AU2700/5400) | Interference < 10% up to 1000 mg/dL | Interference < 4% up to 1000 mg/dL |
| RF (AU2700/5400) | Not specified | Interference < 4% up to 600 IU/mL |
| Ascorbic Acid | Interference < 2-3% up to 20 mg/dL | Not tested |
| Prozone Capacity | No high dose effect up to 3,200 mg/dL | No high dose effect up to 10,000 mg/dL |
Note: Acceptance criteria are inferred based on the performance of the predicate device, as the document states "The following Tables compare the new Olympus IgA (OSR6X171) reagent with the predicate devices..." implying that comparable performance to the predicate is the acceptance standard for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Precision: The sample sizes for the precision studies are not explicitly stated, but "Sample 1," "Sample 2," and "Sample 3" for each instrument suggest multiple measurements were taken for each of these samples. The number of replicates per sample and the total number of samples tested are not provided.
- Method Comparison (Linear Regression): N = 111 samples were used for the method comparison study.
- Interfering Substances: The sample sizes for interference studies are not provided.
- Prozone Capacity: The sample sizes for prozone capacity testing are not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission, it is typically based on prospective studies conducted in controlled laboratory settings for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes an in vitro diagnostic (IVD) reagent, not an AI/CADe device that uses expert-established ground truth from medical images. Therefore, this information is not applicable. For IVDs, the "ground truth" is typically established through reference methods or highly accurate comparative assays. In this case, the predicate device (Olympus IgA (OSR6X44) Reagent) served as the comparator for method comparison, and the "calibration traceability" to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619) provides the ultimate "ground truth" for the quantitative measurements.
4. Adjudication Method for the Test Set
Not applicable, as this is an IVD reagent and not an AI/CADe device involving human expert 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
Not applicable. This is an IVD reagent, not an AI/CADe device, and does not involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is an IVD reagent that performs quantitative measurements on Olympus analyzers. Its performance is inherently standalone in the sense that the measurement results are generated by the instrument and reagent system without human interpretation for the determination of the IgA level itself. The physician then interprets these quantitative results in a clinical context. The performance characteristics described (precision, assay range, method comparison, interference, prozone capacity) all reflect the standalone performance of the reagent on the specified analyzers.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the quantitative determination of IgA, the "ground truth" is implicitly established by:
- Traceability to an International Reference Preparation: The method is traceable to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619). This serves as the primary reference standard for accurate IgA quantification.
- Comparison to a Legally Marketed Predicate Device: The performance is compared against the previously approved Olympus IgA (OSR6X44) Reagent (K951055), which itself would have been validated against accepted reference methods and standards.
8. The Sample Size for the Training Set
Not applicable. This is an IVD reagent, not a machine learning or AI device that uses a "training set" in the conventional sense. The development of such a reagent involves chemical formulation and analytical validation, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The accuracy of the reagent is validated against established quantitative standards and predicate device performance.
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