(61 days)
System reagent for the quantitative determination of IgM 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 IgM reacts specifically with anti-human IgM 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.
The provided 510(k) summary describes a new Olympus IgM reagent (OSR6X173) and compares its performance to a predicate device. This document is a premarket notification for a diagnostic reagent, which falls under IVD (in vitro diagnostic) devices. For IVD devices, the "study" typically refers to analytical and clinical performance studies, not AI-specific studies like MRMC or standalone algorithm performance. Therefore, many of the requested items related to AI device performance (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not directly applicable or reported in this type of submission.
Here's an analysis based on the provided text, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a separate section. Instead, it presents performance characteristics of the new device and the predicate device side-by-side, implying that the new device's performance is acceptable if it is comparable to or better than the predicate. For the purpose of this analysis, I will treat the performance values of the predicate device and the new device as demonstrating acceptable performance through substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Olympus IgM reagent OSR6X173) |
|---|---|---|
| Precision (Total CV%) | ||
| AU400/400e | Sample 1: 1.74% | |
| Sample 2: 1.18% | ||
| Sample 3: 1.49% | Sample 1: 4.03% | |
| Sample 2: 2.95% | ||
| Sample 3: 2.60% | ||
| AU600/640/640e | Sample 1: 2.16% | |
| Sample 2: 1.48% | ||
| Sample 3: 1.35% (for AU600) | ||
| Sample 1: 1.5% | ||
| Sample 2: 1.3% (for AU640/640e) | Sample 1: 3.44% | |
| Sample 2: 3.29% | ||
| Sample 3: 4.08% | ||
| AU2700/5400 | Sample 1: 2.49% | |
| Sample 2: 2.57% | ||
| Sample 3: 3.07% | Sample 1: 3.79% | |
| Sample 2: 3.31% | ||
| Sample 3: 3.52% | ||
| Assay Range | Not explicitly stated, inferred from Method Comparison | 20-500 mg/dL |
| Hook Effect/Prozone | May occur with highly elevated IgM samples > 3,500 mg/dL polyclonal | May occur with highly elevated IgM samples > 10,000 mg/dL polyclonal |
| Method Comparison (Linear Regression) | Slope: 0.968 | |
| Intercept: 0.6 | ||
| R: 0.998 | ||
| N: Not clearly stated in predicate table (appears truncated) | Slope: 1.006 | |
| Intercept: 2.8 | ||
| R: 1.000 | ||
| N: 107 | ||
| Interfering Substances (Bilirubin) | ||
| AU400/400e | Interference less than 2% up to 40 mg/dL | Interference less than 4% up to 40 mg/dL |
| AU600/640/640e | Interference less than 5% up to 40 mg/dL | Interference less than 3% up to 40 mg/dL |
| AU2700/5400 | Interference less than 10% up to 40 mg/dL | Interference less than 8% up to 40 mg/dL |
| Interfering Substances (Hemolysis) | ||
| AU400/400e | Interference less than 2% up to 500 mg/dL | Interference less than 4% up to 500 mg/dL |
| AU600/640/640e | Interference less than 10% up to 500 mg/dL | Interference less than 3% up to 500 mg/dL |
| AU2700/5400 | Interference less than 5% up to 500 mg/dL | Interference less than 3% up to 500 mg/dL |
| Interfering Substances (Lipemia) | ||
| AU400/400e | Interference less than 10% up to 300 mg/dL | Interference less than 10% up to 300 mg/dL |
| AU600/640/640e | Interference less than 10% up to 400 mg/dL | Interference less than 10% up to 300 mg/dL |
| AU2700/5400 | Interference less than 10% up to 400 mg/dL | Interference less than 10% up to 200 mg/dL |
| Interfering Substances (Ascorbic Acid) | ||
| AU400/400e | Interference less than 2% up to 20 mg/dL | Not Tested |
| AU600/640/640e | Interference less than 1% up to 20 mg/dL | Not Tested |
| AU2700/5400 | Interference less than 3% up to 20 mg/dL | Not Tested |
| Functional Sensitivity | Not Specified |
§ 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).