(121 days)
(1) Elecsys Anti-CCP immunoassay: Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Anti-CCP immunoassay is a two step IgG-capture test principle immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The Elecsys Anti-CCP reagent kit consists of a Reagent Pack (R1, R2 and M[streptavidin-coated microparticles]) and lyophilized calibrators 1 and 2.
(2) The Elecsys PreciControl Anti-CCP is a lyophilized product consisting of human serum with added Anti-CCP antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels.
Note: The reagent is packaged with calibrators; controls are packaged separately.
Here's a summary of the acceptance criteria and study findings for the Elecsys Anti-CCP Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys Anti-CCP Immunoassay are implicitly defined by its performance in comparison to the predicate device, the Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit (K052133). The goal is to demonstrate "substantial equivalence."
| Feature/Acceptance Criteria Category | Elecsys Anti-CCP Assay Performance | Predicate Device Performance (Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit) |
|---|---|---|
| Precision | Elecsys 2010 and cobas e 411: | |
| Total CV: | ||
| 3.1% CV @ 16.9 U/mL | ||
| 4.5% CV @ 356 U/mL | ||
| 3.0% CV @ 24.6 U/mL | ||
| 2.5% CV @ 137 U/mL | ||
| Within-run CV: | ||
| 0.6% CV @ 16.9 U/mL | ||
| 2.3% CV @ 356 U/mL | ||
| 1.0% CV @ 24.6 U/mL | ||
| 1.4% CV @ 137 U/mL | Intra-assay Precision: | |
| 12.8%CV @ 1007.4 U/mL | ||
| 6.5% CV @ 240.1 U/mL | ||
| 7.0%CV @ 95.7 U/mL | ||
| 8.4% CV @ 51.7 U/mL | ||
| 8.1% CV @ 33.6 U/mL | ||
| 4.3% CV @ 88.1 U/mL | ||
| Inter-assay Precision: | ||
| 11.7% CV @ 1105.9 U/mL | ||
| 7.9% CV @ 257.4 U/mL | ||
| 6.0% CV @ 93.1 U/mL | ||
| 7.8% CV @ 52.5 U/mL | ||
| 14.5% CV @ 33.3 U/mL | ||
| 17.7% CV @ 94.9 U/mL | ||
| LoQ (Functional Sensitivity) | 8 U/mL | N/A (Not given for predicate) |
| LoB (Limit of Blank) | ≤ 7 U/mL | N/A (Not given for predicate) |
| LoD (Limit of Detection / Analytical Sensitivity) | ≤ 8 U/mL | N/A (Not given for predicate, but LDL is 1.6 U/mL) |
| LDL (Lower Detection Limit) | N/A (Not given for Elecsys) | 1.6 U/mL |
| Measuring Range | 8 – 1000 U/mL (defined by the limit of detection and the maximum of the master curve) | 1.6 – 1600 U/mL |
| Method Comparison (Agreement vs. Predicate) | Positive Percent Agreement = 94.3% (95% CI = 91.7 – 96.2) | |
| Negative Percent Agreement = 98.4% (95% CI = 97.5 – 99.1) | ||
| Total Percent Agreement = 97.3% (95% CI = 96.3 – 98.0) | Predicate compared to alternative ELISA: | |
| Positive Percent Agreement = 99.3% (95% CI = 93.2 – 100%) | ||
| Negative Percent Agreement = 96.7% (95% CI = 81.6 – 99.9%) | ||
| Overall Percent Agreement = 97.8% (95% CI = 93.2 – 100%) | ||
| Interference (Bilirubin) | Unaffected by: |
§ 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).