K-ASSAY CRP (Ver.2)

The K-ASSAY CRP (Ver.2) is a C-reactive protein immunological test system that quantifies CRP levels in human serum and plasma using an immunoturbidimetric assay. It measures CRP concentration to aid in detecting and evaluating infection, tissue injury, inflammatory disorders, and related diseases for in vitro diagnostic use.

The device uses latex particles coated with goat polyclonal antibodies specific to human CRP. It employs 6-level calibration (0.0, 10.0, 50.0, 150.0, 300.0, and 400.0 mg/L) with a measurement range of 5.0–400.0 mg/L, compared to the predicate's 0.2–480 mg/L range and multi-point calibrators with 5 levels each. Both use latex-enhanced immunoturbidimetric assay technology.

CLSI guidelines were used: EP05-A3 (precision evaluation), EP06-Ed2 (linearity), EP07 (interference testing), EP09c (method comparison), EP17-A2 (detection capability), EP25-Ed2 (reagent stability), and EP28-A3c (reference intervals). FDA's September 2005 guidance on CRP, hsCRP, and cCRP assay review criteria was also applied.

Substantial equivalence is demonstrated through direct method comparison showing excellent correlation (r=0.999, y=1.005x-0.002) with 175 clinical serum samples, comparable precision across single-site and multi-site studies (CV 0.4–2.5%), identical assay methodology (latex-enhanced immunoturbidimetry), and equivalent interference testing showing no significant interference from clinically relevant endogenous and exogenous substances. Both devices are Class II with the same product code (DCK) and share the same indications for use in quantifying CRP for clinical assessment.