Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

The Rapicide PA High-Level Disinfection Test Strip is a chemical indicator strip designed to verify that Rapicide PA high-level disinfectant solution meets the minimum recommended concentration of 850 ppm peracetic acid. The strip turns solid black when the disinfectant concentration is adequate, and displays gray or white coloring when concentration is below the threshold. It is used by trained personnel in endoscopy facilities to validate proper disinfection of endoscopes and accessories.

The subject device uses a polypropylene vial containing 100 test strips per vial (compared to aluminum vial with 50 strips in the predicate). It has increased strip length, modified adhesive type, and sources chromatography paper from a different supplier. However, the endpoint specification (solid black at >850 ppm PAA), minimum recommended concentration, and stability profile remain identical to the predicate device.

Not stated in this summary.

The subject device is substantially equivalent because it measures the same analyte (peracetic acid concentration) with identical performance specifications and endpoint criteria as the predicate K152394. Although packaging materials changed from aluminum to polypropylene and the strip count per vial increased from 50 to 100, the fundamental chemistry, dynamic range, sensitivity, specificity, and shelf life all remain identical. Testing demonstrated that all performance parameters—including dynamic range, comparative sensitivity/specificity, and analytic specificity—met acceptance criteria, establishing that the device performs as safely and effectively as the legally marketed predicate device.