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510(k) Data Aggregation
K Number
K242170Device Name
K-ASSAY CRP (Ver.2)
Manufacturer
Kamiya Biomedical Company, LLC
Date Cleared
2025-04-18
(268 days)
Product Code
DCK
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
Kamiya Biomedical Company, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-ASSAY® CRP (Ver.2) is intended to be used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma (potassium-EDTA or lithium-heparin) by immunoturbidimetric assay. Measurement of CRP aids in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The K-ASSAY® CRP (Ver.2) assay quantifies C-reactive protein based on immunoturbidimetric assay. The reagent uses latex combined with goat polyclonal antibody specific to human CRP. By adsorbing CRP in the sample to the surface of the latex particles and reacting it with the anti-CRP antibody, specific aggregation corresponding to the CRP concentration occurs. Since the absorbance of the reaction changes in proportion to the amount of aggregation, the concentration of CRP in the sample is determined based on the calibration curve prepared using a standard of known CRP concentrations. The K-ASSAY® CRP (Ver.2) assay can be run using a chemistry analyzer. 6 levels of calibrators from the K-ASSAY® CRP Calibrator (Ver.2) calibrators are used for quantifying the levels of CRP present in the patient's sample.
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