(335 days)
Yumizen C1200 CRP reagent is intended for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and lithium heparin plased on an immunoturbidimetric assay. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infections, tissue injury and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.
Yumizen C1200 CRP (Licensed for USP6, 248, 597/ USP6, 828, 158 and equivalent patents in other countries) is a latex-enhanced immunoturbidimetric assay developed to accurately measure CRP levels in serum and plasma samples for conventional CRP ranges.
When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP antibody which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
Reagents Yumizen C1200 CRP is ready-to-use.
Reagent 1: Buffer solution: Glycine buffer solution Reagent 2: Latex suspension: 0.20% w/v suspension of latex particles sensitized with anti-CRP antibodies (rabbit)
After measurements are taken, reagent cassettes should remain in the refrigerated tray.
Care should be taken not to interchange the caps with others cassettes.
Reagents with different lot numbers should not be interchanged or mixed.
This submission consists of the Yumizen C1200 CRP (1300023877) reagent for serum and plasma testing for Yumizen C1200 reagent CRP, the submission includes the controls Yumizen C1200 Level 1 Protein Control (1300023944) and Yumizen C1200 Level 2 Protein Control (1300023945) for use on Yumizen C1200 Analyzer. The submission for Yumizen C1200 reagent CRP also includes the corresponding calibrator Yumizen C1200 CRP Cal (1300023899) for use on Yumizen C1200 Analyzer.
The acceptance criteria and study proving the device meets them are detailed below for the Yumizen C1200 CRP reagent.
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range | Limit of Quantitation (LOQ): Not explicitly stated as an acceptance criterion, but determined according to CLSI EP17-A2. | LOQ: 5 mg/L (Serum) |
| Linearity: Not explicitly stated as an acceptance criterion, but evaluated according to CLSI EP06-A. Range should cover desirable range and extend to lowest and highest ends. | Linearity Range: 9.42 to 150.78 mg/L (Serum) | |
| Measuring Range: Not explicitly stated as an acceptance criterion, but based on LOQ and linearity studies. | Measuring Range: 5.0 to 160 mg/L (until 800 mg/L with post-dilution) | |
| Accuracy and Precision | Within-run CV limits: Low level: 9.0%, Middle level: 4.5%, High level: 3.8% | Within-run CV: All reported values for samples and controls are well below the limits (e.g., 0.8% - 1.8%) |
| Total precision CV limits: Low level: 12.0%, Middle level: 6.0%, High level: 5.0% | Total Precision CV: All reported values for samples and controls are well below the limits (e.g., 1.5% - 2.9%) | |
| Interferences | Acceptable bias is defined at +/-10% of the value without interfering substances. | Highest reported values for various interferents show no interference higher than 10%. |
| Matrix Comparison | Not explicitly stated as an acceptance criterion, but results should show no significant difference between serum and plasma with heparin specimens. | Correlation (R) of 0.996 and slope (0.8973 – 1.007) and intercept (-0.1611 – +0.6459) for 38 samples; concluded "no significative difference." |
| Method Comparison | Not explicitly stated as an acceptance criterion, but evaluated using NCCLS (CLSI) EP-9A3. | Correlation (R2) of 0.998 and slope (0.9680 – 0.9976) and intercept (-0.1357 – +0.6287) for 102 samples. |
| Reagent Stability | Closed stability: Stable up to the expiry date on the label if stored at 2-10°C. | Shelf Life: 24 months. |
| Open stability (on-board): Not explicitly stated as an acceptance criterion, but assessed. | On-board stability: 8 weeks. | |
| Reference Range | Verification studies should support established reference ranges in literature for adults: 20-60 years |
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).