(78 days)
The IMMULITE® IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP is a solid-phase, chemiluminescent immunometric assay. The assay utilizes a 14-inch polystyrene bead coated with anti-ligand. The bead is co-incubated with sample, murine monoclonal anti-CRP, and alkaline phosphatase (bovine calf intestine)-conjugated to rabbit polyclonal anti-CRP in buffer for 30 minutes on each IMMULITE/IMMULITE 1000 and IMMULITE 2000 platform. Unbound enzyme conjugate is removed by a centrifugal wash procedure. Substrate is added and the resulting chemiluminescence is read in the luminometer.
The IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 High Sensitivity CRP assays are immunological test systems designed for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma. These devices are intended to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, associated diseases, and in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP measurements, when used with traditional clinical evaluations of acute coronary syndrome, may also serve as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (from predicate/literature) | IMMULITE/IMMULITE 1000 Performance (Reported) | IMMULITE 2000 Performance (Reported) |
|---|---|---|---|
| Working Range | Predicate: 0.175 to 1100 mg/L | 0.3 to 100 mg/L | 0.2 to 100 mg/L |
| Analytical Sensitivity | Predicate: 0.175 mg/L | 0.1 mg/L | 0.1 mg/L |
| Functional Sensitivity | Not reported in predicate | 0.3 mg/L (at 10% CV) | 0.2 mg/L (at 10% CV) |
| Precision (Intra-assay CV%) | Predicate not explicitly stated for specific levels. Literature-based expectations for CRP assays. | Did not exceed 6.0% (0.3-78 mg/L) | Did not exceed 8.7% (0.23-93.7 mg/L) |
| Precision (Inter-assay CV%) | Predicate not explicitly stated for specific levels. Literature-based expectations for CRP assays. | Not greater than 7.5% (0.8 mg/L), 6% (1.5 mg/L), 4.8% (3.1 mg/L), 4.9% (15.0 mg/L). Did not exceed 10% (0.3-78 mg/L). | Not greater than 7.1% (0.85 mg/L), 3.1% (3.2 mg/L), 3.3% (12.3 mg/L). Did not exceed 8.7% (0.23-93.7 mg/L). |
| Linearity | Demonstrated | Demonstrated within precision of the assay | Demonstrated within precision of the assay |
| Spiked Recovery | Demonstrated | Demonstrated within precision of the assay | Demonstrated within precision of the assay |
| Interference (Bilirubin) | Predicate: No significant interference up to 230 mg/L | No effect up to 200 mg/L | No effect up to 200 mg/L |
| Interference (Hemoglobin) | Predicate: No significant interference up to 36 g/L (36000 mg/L) | No effect up to 570 mg/L | No effect up to 512 mg/L |
| Interference (Triglycerides) | Predicate: No significant interference up to 7.4 g/L (7400 mg/L) | No effect up to 3000 mg/L | No effect up to 3000 mg/L |
| Cross-Reactivity | Not specified for predicate | No cross-reactivity (HSA, IgG, Transferrin) | No cross-reactivity (HSA, IgG, Transferrin) |
| High Dose Hook Effect | Not reported in predicate | No hook effect up to 3780 mg/L | No hook effect up to 3780 mg/L |
| Method Comparison (Regression) | Substantial equivalence to predicate (slope ~1, intercept ~0, r > 0.95 generally for IVDs) | IMMULITE/IMMULITE 1000 vs. Dade Behring HSCRP: | |
| Full range (N=175): slope = 0.952, intercept = 0.022, r = 0.996 |
§ 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).