DISINTEK™ PA Test Strips

The DISINTEK™ PA Test Strip is a chemical indicator that detects whether peracetic acid concentration in RAPICIDE™ PA high-level disinfectant solution meets or exceeds the 850 ppm minimum recommended concentration (MRC) at both 30°C and 20°C. The single-use strip features a 0.2-inch × 0.2-inch chemically-treated indicator pad attached to a plastic handle that changes color to indicate pass or fail results.

The device uses a multi-step chemistry where a reducing agent neutralizes PAA up to the MRC threshold, and excess PAA above this level reacts with a halide and redox indicators to produce a green color change (yellow to green) within 25-30 seconds, compared to the predicate's iodide-starch chemistry that produces solid black coloration. Both devices have identical physical dimensions and measure the same analyte, but differ in their indicator agents and resulting color outputs.

Not stated in this summary.

The DISINTEK PA Test Strip is substantially equivalent because it shares the same intended use as the predicate device—both reliably detect whether peracetic acid concentration is above or below 850 ppm MRC at both temperature ranges. Although the chemistry differs (redox indicators versus iodide-starch), comparative testing demonstrated 100% sensitivity and 100% specificity matching the predicate's performance. The differences in colorimetric approach do not impact safety or effectiveness since both devices accurately classify solutions as pass or fail, and the risk from color differences is mitigated through validated instructions and color charts that ensure proper user interpretation.