(135 days)
The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device into ded to measure C-Reactive Protein in human serum. Measurements of CRP are used in the evaluation and treatment on injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.
This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ADVIA IMS High Sensitivity C-Reactive Protein (CRP) Method based on the 510(k) summary:
Acceptance Criteria and Device Performance for ADVIA IMS High Sensitivity C-Reactive Protein (CRP) Method
This device intends to quantitatively measure C-reactive protein (CRP) in serum, primarily for evaluating and treating tissue injuries and monitoring traumatic injuries, rheumatic fever, and rheumatoid arthritis. The study compares the performance of the ADVIA IMS CRP assay against a predicate device, the Dade/Behring N High Sensitivity CRP (K991385).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this diagnostic device are typically established by demonstrating substantial equivalence to a legally marketed predicate device, focusing on analytical performance characteristics such as imprecision, correlation, and interference.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS CRP) |
|---|---|---|
| Imprecision (Normal Range) | ||
| Level 1 (16.5 mg/L) | Total CV |
§ 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).