FDA 510K for C-Reactive Protein Immunological Test System
The C-Reactive Protein (CRP) Immunological Test System is an in-vitro diagnostic assay that measures CRP levels in human serum, plasma, or bodily fluids. CRP is a key biomarker for inflammation, with elevated levels indicating conditions like infections, tissue injury, and inflammatory diseases. This assay typically uses particle-enhanced immunonephelometric to quantify CRP and assist in diagnosing and monitoring inflammatory conditions, cardiovascular diseases, and heart disease risk.
Intended Use of C-Reactive Protein Immunological Test System
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for C-Reactive Protein Immunological Test System
FDA 510K for C-Reactive Protein Immunological Test System Device Code and Regulation Number
Cardiac C-Reactive Protein, Antigen, Antiserum, and Control
Intended Use
It is an in-vitro diagnostic test designed to measure C-reactive protein (CRP) in human serum, heparin, and EDTA plasma using particle-enhanced immunonephelometric, aiding in cardiac risk assessment, as elevated CRP levels are associated with infections, tissue injury, inflammatory disorders, and cardiovascular disease, with high-sensitivity CRP (hsCRP) serving as a risk marker for assessing prognosis in patients with coronary disease, utilizing polystyrene particles coated with monoclonal antibodies to CRP.
Device Description
It is an in vitro diagnostic reagent designed for the quantitative determination of C-reactive protein (CRP) in human serum, heparinized, and EDTA plasma. This assay utilizes a particle-enhanced immunoassay method where polystyrene particles coated with monoclonal antibodies specific to human CRP aggregate when mixed with samples containing CRP. The resulting aggregates scatter light, and the intensity of the scattered light is proportional to the CRP concentration in the sample, with results being evaluated by comparison to a known concentration standard.
C-Reactive Protein, Antigen, Antiserum, and Control
Intended Use
It is an in-vitro diagnostic test that utilizes a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. The assay is conducted using the Analyzer and aids in the evaluation of tissue injury, infection, and inflammatory disorders. Designed for use by trained professionals in clinical laboratories, this test is not intended for point-of-care use.
Device Description
It is a homogeneous sandwich immunoassay that uses fluorescence resonance energy transfer (FRET) to detect and quantify C-Reactive Protein (CRP). In this process, a donor fluorophore transfers excitation energy to an acceptor fluorophore in proximity, emitting light. The emitted light intensity is proportional to the amount of CRP present. The assay is competitive, where a monoclonal anti-CRP antibody is labeled with the donor fluorophore, and CRP antigen is labeled with the acceptor fluorophore. As CRP concentration increases, the signal decreases proportionally.
System, Test, C-Reactive Protein
Intended Use
It is an in vitro diagnostic test for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of CRP helps in the detection and evaluation of infection, tissue injury, inflammatory disorders, and related diseases.
Device Description
The RCRP method utilizes a particle-enhanced turbidimetric immunoassay (PETIA) technique, where synthetic particles coated with an antibody to C-Reactive Protein (AbPR) aggregate in the presence of CRP in the sample. The resulting increase in turbidity is proportional to the concentration of C-Reactive Protein.
Performance Testing (Analytical) for C-Reactive Protein Immunological Test System
- Precision (Reproducibility and Repeatability)
- Linearity
- Analytical Specificity/Interference
- Endogenous Interference
- Albumin, Immunoglobulin (IgG) and Rheumatoid Factors Interference
- Exogenous Interferences – Drugs
- Assay Reportable Range
- Accuracy
- Comparison Studies
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
- Limit of Detection (LoD), Limit of Quantification (LoQ) and Limit of Blank (LoB)
- Expected Values/Reference Range
- Reagent Stability
- Shelf life
Clinical Testing
No Guidance available for 510k submission