Rheumatoid Factor Immunological Test System

A Rheumatoid Factor (RF) Immunological Test System, classified as an In Vitro Diagnostic (IVD) device, is a medical laboratory tool used to detect the presence and measure the level of rheumatoid factor antibodies in a patient’s blood sample, primarily to help diagnose conditions like rheumatoid arthritis (RA) by identifying the specific immune response associated with the disease; it typically works by mixing the blood sample with latex beads coated with antibodies, where the presence of RF causes the beads to clump together, indicating a positive result, and can be analysed using various methods like agglutination or nephelometry depending on the system design.

Intended Use of Rheumatoid Factor Immunological Test System

A Rheumatoid Factor Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Intended Use:

Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

Device Description:

The Rheumatoid Factor Kit includes reaction buffer, latex reagent, RF controls, and a RF calibration device. It includes pH 8.3, Sodium Chloride, Sodium Ethylenediamine, bovine serum albumin, and 0.09% w/v sodium azide. The kit is ready for use.

• Reagent Stability
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Accuracy
• Analytical specificity

Clinical Testing:

No Guidance available  for 510k submission