(35 days)
For in vitro diagnostic use only. VITROS Chemistry Products C3 Reagent is used to quantitatively measure complement C3 (C3) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.
For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products C4 Reagent is used to quantitatively measure complement C4 (C4) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
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 System 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 C3 Reagent, VITROS Chemistry Products C4 Reagent, VITROS Chemistry Products Calibrator Kit 20 and VITROS Chemistry Products Protein Performance Verifiers I, II and III), which are combined on the VITROS 5,1 FS Chemistry System to perform the VITROS C3 and C4 assays.
- 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).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The document describes the submission of a 510(k) premarket notification for several in vitro diagnostic devices, including VITROS Chemistry Products C3 Reagent, VITROS Chemistry Products C4 Reagent, VITROS Chemistry Products Calibrator Kit 20, and VITROS Chemistry Products Protein Performance Verifiers I, II and III. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for a new clinical performance study. Instead, the "acceptance criteria" are implied by the statistical correlation to the predicate devices.
| Device Characteristic | VITROS C3 assay (New Device #1) | Beckman C3 assay (Predicate Device #1) | VITROS C4 assay (New Device #2) | Dade Behring C4 assay (Predicate Device #2) |
|---|---|---|---|---|
| Correlation to Predicate | Y = 0.95X + 11 mg/dL | N/A | Y = 0.93X + 3.0 mg/dL | N/A |
| Correlation Coefficient (r) | 0.98 | N/A | 0.976 | N/A |
| Reportable Range | 40 - 380 mg/dL | 35 - 350 mg/dL | 8.0 - 60.0 mg/dL | 6 - 190 mg/dL |
| Method | Immunoturbidimetry | Rate nephelometry | Immunoturbidimetry | Rate nephelometry |
| Instrumentation | VITROS 5,1 FS Chemistry Systems | IMMAGE Immunochemistry Systems | VITROS 5,1 FS Chemistry Systems | Dade Behring BN® ProSpec Nephelometer |
| Sample type | Serum and plasma | Serum | Serum and plasma | Serum |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size used for the correlation studies for C3 and C4 assays, nor does it specify the country of origin of the data. It generally refers to "patient samples" and "commercially available reagents." The studies appear to be retrospective analyses comparing the new device's performance to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The ground truth for the test set is established by the results obtained from the predicate devices, which are already legally marketed and established diagnostic systems. There is no mention of expert consensus for establishing ground truth in this submission.
4. Adjudication Method for the Test Set:
Not applicable. The study design involves direct comparison and correlation between the new device's measurements and those of the predicate devices. There is no mention of an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This document describes the performance of an in vitro diagnostic device (reagents and calibrators) used in a laboratory setting for quantitative measurement. It is not an imaging device or a system that involves human readers interpreting cases in a multi-reader, multi-case study.
6. Standalone Performance Study:
Yes, a standalone performance study in the form of correlation studies, precision, analytical sensitivity, specificity, and expected values was performed for the VITROS C3 and C4 assays, comparing them to the predicate devices. This demonstrates the algorithm-only performance in relation to established methods.
7. Type of Ground Truth Used:
The ground truth used for these studies is the measurement values obtained from the legally marketed predicate devices. The new devices' performance is assessed by how well their results correlate with those produced by the predicate devices.
8. Sample Size for the Training Set:
The document does not explicitly state a "training set" sample size in the context of machine learning or AI models. The development and validation of these in vitro diagnostic reagents would have involved extensive R&D and internal testing, which would serve a similar function to a training set, but no specific numbers are publicly disclosed in this 510(k) summary.
9. How Ground Truth for the Training Set Was Established:
Not explicitly stated. For in vitro diagnostic devices, the "training" (development and optimization) would typically involve using known reference materials, spiked samples, and characterized patient samples, with their true values established through highly accurate reference methods or clinical standards. This information is usually part of internal development and not fully detailed in a 510(k) summary focused on substantial equivalence.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).