(73 days)
For in vitro diagnostic use only. VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF).
For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5.1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents.
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products RF Reagent, VITROS Chemistry Products Calibrator Kit 16 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS RF assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports.
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Here's a breakdown of the acceptance criteria and study information for the VITROS Chemistry Products RF assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting specific numerical acceptance criteria for a novel performance study beyond correlation. The key performance indicator is the correlation with the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate | High correlation with predicate device (Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay) | Correlation coefficient of 0.986 |
| Regression Equation (VITROS RF vs. Predicate) | Close relationship demonstrating substantial equivalence | VITROS RF = 0.904 x X - 4.045 (IU/mL) |
| Precision | Acceptable precision for diagnostic use (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Specificity | Acceptable specificity (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Linearity | Acceptable linearity across reportable range (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Antigen Excess | Acceptable performance regarding antigen excess (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Lower Limit of Detection | Acceptable lower limit of detection (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Expected Values | Acceptable expected values (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples."
- Sample Size for Test Set: Not explicitly stated in the provided summary.
- Data Provenance: "patient samples" (retrospective or prospective is not specified, nor is country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of in vitro diagnostic device (IVD) submission. Ground truth for an IVD measuring a quantitative analyte like rheumatoid factor is typically established by comparing its results against a "gold standard" or predicate method (another established IVD). Expert interpretation of images or clinical cases, which would require experts, is not the primary method for establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an IVD device measuring a quantitative analyte, not subject to expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices where human readers interpret and classify images, and the AI assists in that interpretation. The VITROS RF assay is a quantitative laboratory test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance study appears to be a standalone or algorithm-only evaluation. The VITROS RF assay is an automated in vitro diagnostic test performed on the VITROS 5,1 FS Chemistry System. Its performance is compared directly to another device (the predicate) and evaluated for analytical characteristics (precision, linearity, etc.) without human interpretation affecting the result of the assay itself.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation, in this context, is the results obtained from the legally marketed predicate device (Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay). The study aimed to demonstrate substantial equivalence by correlating the new device's measurements with those of the predicate device using patient samples.
8. The Sample Size for the Training Set
The provided summary does not mention a "training set" in the context of an AI/machine learning model. This device is an immunoassay (quantitative chemical test) and not an AI/ML software device in the modern sense that would require a distinct training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is an immunoassay, not an AI/ML algorithm requiring a training set with established ground truth. The development of such assays involves analytical method development and validation, not model training.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).