(194 days)
The ADVIA CHEMISTRY C-Reactive Protein_2 assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin) on the ADVIA Chemistry systems. Such measurements are used in the evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Increases in CRP values are non-specific for many disease processes and should not be interpreted without a complete clinical evaluation.
The ADVIA Chemistry C-Reactive Protein_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the C-Reactive Protein 2 (CRP 2) method.
The ADVIA Chemistry C-Reactive Protein_2 (CRP_2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein in human serum and plasma on the ADVIA® Chemistry systems. The ADVIA Chemistry C-Reactive Protein_2 Calibrators are used to calibrate this method. The proposed labeling indicates the ADVIA Chemistry CRP_2 reagents and Calibrators are for use on the family of ADVIA Chemistry Systems (1200 / 1650 / 1800 / 2400).
The CRP_2 latex reagent is a suspension of uniform polystyrene latex particles coated with rabbit anti-CRP antibody. When serum or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting in an increase in the turbidity. This turbidity is measured at 571 nm. The CRP concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.
The ADVIA® Chemistry C-Reactive Protein_2 Calibrators consist of six (6) levels of protein stabilized matrices containing varying concentrations of recombinant human CRP. The Calibrators have targeted expected values (lot specific) of 0, 5, 20, 40, 160, and 320 mg/L.
The calibrators (1 mL/vial) and ready to use. Storage is at 2 - 8℃.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:
This document describes an in vitro diagnostic (IVD) device, specifically an assay and calibrators for measuring C-Reactive Protein (CRP). The acceptance criteria are primarily focused on demonstrating substantial equivalence to existing predicate devices through performance studies.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this IVD device are implicitly defined by demonstrating performance that is comparable to or better than the predicate device across various analytical characteristics.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (ADVIA Chemistry C-Reactive Protein_2) |
|---|---|---|
| Imprecision (Total CV) | Comparable to or better than predicate device | ADVIA 1650: |
| - CRP level 31 mg/L: 1.3% | ||
| - CRP level 56 mg/L: 1.1% | ||
| - CRP level 83 mg/L: 1.5% | ||
| - CRP level 221 mg/L: 1.5% | ||
| Correlation ($r$) | Strong correlation (e.g., $r \ge 0.975$) with predicate | 0.990 (Serum, ADVIA 1650 vs. ADVIA 1650 CRP) |
| & Linear Regression | Slope near 1.0, intercept near 0.0 | $Y = 0.99x - 2.8$ |
| Analytical Range | Meet specified clinical range and compare to predicate | 4 to Calibrator 6 (304-336) mg/L on ADVIA 1650 |
| Interfering Substances | Minimal clinically significant interference | Hemoglobin (1000 mg/dL): 0.7% change |
| (e.g., % change |
§ 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).