Celerity 5 HP Biological Indicator (LCB052)

The Celerity 5 HP Biological Indicator is a sterilization process monitoring device containing Geobacillus stearothermophilus spores and nutrient media in a plastic vial. When exposed to low-temperature hydrogen peroxide sterilization cycles and incubated with the Celerity HP Incubator, it produces a fluorescent signal within 5 minutes to confirm the effectiveness of the sterilization process.

The device uses the same indicator organism (Geobacillus stearothermophilus), identical mechanism of action (enzyme-fluorogenic substrate reaction), same viable spore population (1.0–4.0 × 10⁶ spores/BI), equivalent resistance characteristics, identical culture conditions (55–59°C, 5-minute incubation), and same primary packaging as the predicate device K223717. The only modification is lowered survival resistance at 3.5 mg/L H₂O₂ in addition to the predicate's 9.1 mg/L specification.

Not stated in this summary. The document references ISO 13485 clauses in the general control requirements section but does not cite specific consensus standards for performance testing.

The subject device is substantially equivalent to predicate K223717 because it has identical intended use, same organism and mechanism of action, equivalent technological characteristics, and passed comparative performance testing (All Survive testing and dose response testing). The lowered resistance specification actually provides greater sterilization assurance, making the device as safe and effective as the predicate.