Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

These are biological indicators (BIs) and challenge packs used to monitor vapor-phase hydrogen peroxide sterilization cycles in low-temperature sterilization systems (V-PRO and STERRAD models). The Celerity 5 HP BI provides a fluorescent result within 5 minutes using Geobacillus stearothermophilus spores, while the Celerity 20 HP BI provides results within 20 minutes. Challenge packs are used for periodic qualification testing of sterilizers following installation, relocation, or repairs.

Both devices use the same indicator organism (Geobacillus stearothermophilus), viable spore population (1.0–4.0 × 10⁶ spores/BI), mechanism of action (enzyme-fluorogenic substrate reaction), and resistance characteristics (D-value >6 sec, Survival Time ≥4 sec, Kill Time ≤6 min at 9.1 mg/L H₂O₂). The primary differences are incubation time (5 vs. 20 minutes) and expanded sterilizer cycle coverage (addition of Specialty Cycle and STERRAD 100NX models; removal of STERRAD 100S). Shelf-life targets improved from 10 months to 3 months with a goal of 24 months.

Not stated in this summary.

The subject devices are substantially equivalent because they maintain identical biological performance characteristics (organism type, spore load, resistance profile, culture conditions, primary packaging, and chemical indicator) as their respective predicates. The expanded sterilizer cycle support (addition of Specialty Cycle and removal of obsolete STERRAD 100S) does not alter the fundamental safety or effectiveness, as demonstrated by passing all performance tests including reduced incubation time testing, simulated use testing, bacteriostasis, stability, and specialty cycle validation. The intended use remains the same—routine monitoring and qualification testing of low-temperature sterilization systems—and all performance criteria match or exceed predicate specifications.