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

The Celerity 5 HP and 20 HP Biological Indicators are sterile processing monitoring devices containing Geobacillus stearothermophilus spores used to verify the effectiveness of low-temperature hydrogen peroxide sterilization cycles. When exposed to sterilization and then incubated with the Celerity Incubator, they produce a fluorescent signal within 5 minutes (5 HP) or 20 minutes (20 HP) to confirm sterilizer efficacy. The Challenge Packs are similar indicators combined with a chemical indicator, used for qualification testing of sterilizers following installation, relocation, or major repairs.

Both proposed and predicate devices use identical Geobacillus stearothermophilus spore populations (1.0–4.0 × 10⁶ CFU/BI), the same enzyme-based fluorogenic detection mechanism, identical resistance characteristics (D-value >6 sec, survival time ≥4 sec, kill time ≤6 min at 9.1 mg/L H₂O₂), and the same 55–60°C culture conditions. The primary change is packaging: replacement of cellophane wrapper with a laminated pouch, with establishment of a 3-month in-use shelf-life after pouch opening (extending the original 3-month shelf-life claim to 7 months when stored unopened in the new laminated pouch).

Not stated in this summary. The document describes reduced incubation time testing, simulated use testing, cap media testing, and stability testing (population, D-value, survival/kill, RIT, and media testing), but does not cite specific ISO, IEC, or ASTM standards.

The subject devices are substantially equivalent because they maintain identical intended use (routine monitoring of the same sterilizer cycles), identical indicator organism and viable spore population, identical mechanism of action (enzyme-fluorogenic substrate reaction), identical resistance characteristics, identical culture conditions, and identical primary packaging materials—only the secondary container (pouch material and labeling) has changed to improve shelf-life stability while maintaining performance. All performance tests (reduced incubation time, simulated use, cap media, and stability) passed with identical acceptance criteria, demonstrating that the change in secondary packaging and shelf-life claims does not alter the device's safety, effectiveness, or performance compared to the predicate.