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510(k) Data Aggregation
(71 days)
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.
The Optilite IgM CSF Kit comprises the following reagents:
Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
The provided text describes the 510(k) submission for the Optilite IgM CSF Kit, an in vitro diagnostic device, not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria, such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.
The acceptance criteria and device performance evaluation for this diagnostic kit are centered on analytical performance characteristics, which are standard for laboratory assays.
Here's a breakdown of the applicable information from the provided text:
1. Table of acceptance criteria and the reported device performance:
| Performance Characteristic | Acceptance Criteria (from CLSI Guidelines and Internal Standards) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Total Precision (%CV) | <10% | Level 1: 7.2%Level 2: 5.9%Level 3: 3.6%Level 4: 4.2% |
| Within-run Precision (%CV) | <5% | Level 1: 3.9%Level 2: 2.8%Level 3: 2.2%Level 4: 2.3% |
| Between-run Precision (%CV) | <8% | Level 1: 1.5%Level 2: 2.5%Level 3: 2.6%Level 4: 2.9% |
| Between-day Precision (%CV) | <8% | Level 1: 5.9%Level 2: 4.6%Level 3: 1.3%Level 4: 2.0% |
| Linearity/Assay Reportable Range | Deviation from linearity <10% over the measuring range | Confirmed over 0.07 - 4.55 mg/L with deviation from linearity <10% |
| Detection Limit (LoQ) | Not explicitly stated as a numerical criterion, but defined as the bottom of the measuring range. | 0.11 mg/L (bottom of measuring range) |
| Analytical Specificity (Interference) | Mean results from spiked samples within 10% of control samples. | Not affected by Acetaminophen (1324µmol/L), Acetylsalicylic Acid (3.62mmol/L), Bilirubin (80mg/L), Haemoglobin (1g/L) |
| Method Comparison (Regression Analysis) | Not explicitly stated as a numerical criterion for slope/intercept, but implied to show substantial equivalence. | N=155 samples, Slope: 1.02, 95% CI: 1.00 to 1.04; Intercept: 0.07, 95% CI: 0.03 to 0.09; Pearson's r: 0.997 |
2. Sample size used for the test set and the data provenance:
- Precision Study: 4 sample preparations tested (details on the specific number of aliquots or patient samples composing these preparations are not given). The study design involved 2 runs per day (each in duplicate) over 5 days using 3 analyzers.
- Linearity Study: A serially diluted sample was used. Specific N is not provided.
- Detection Limit (LoQ) Study: The study was based on CLSI EP17-A2. Specific N is not provided.
- Analytical Specificity (Interference) Study: Samples at different IgM concentrations were spiked with interfering substances and tested. Specific N is not provided.
- Method Comparison Study: A total of 239 samples were initially tested, including 219 native CSF samples and 20 patient samples spiked with purified IgM. 155 of these samples were within the measuring range and used for regression analysis.
- Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the samples would be human CSF.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a quantitative immunodiagnostic assay, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for this device's performance is established by reference methods, international standards (ERM-DA470k/IFCC), and the inherent accuracy and precision of the measurements themselves validated against established statistical methodologies (CLSI guidelines).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a quantitative diagnostic assay, not a subjective interpretation task that requires 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, as this is not an AI/ML-based device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an automated turbidimetric analyzer (Optilite) performing a quantitative assay. Its performance is inherently "standalone" in the sense that the instrument provides a numerical result without human interpretation being part of the result generation. The performance metrics presented (precision, linearity, detection limit, method comparison) are its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth or reference for this quantitative assay is:
- Traceability: Established through calibration traceable to the ERM-DA470k/IFCC international reference material.
- Method Comparison: Comparison against a legally marketed predicate device (Human IgM CSF Kit for use on SPAPLUS K120750) using patient samples. The predicate device itself serves as a reference point for substantial equivalence.
- Statistical Methodologies: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines for evaluating precision, linearity, detection capability, and interference.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
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