Celerity Incubator

The Celerity Incubator is a Class II medical device that incubates and automatically reads fluorescent biological indicators (BIs) used to validate steam and vaporized hydrogen peroxide sterilization cycles. It operates at 55–60°C, detects fluorescence signals from viable organisms in the BI media using UV LEDs and a photodiode, and displays results via audible alarm, LED lights, and LCD screen within 5 or 20 minutes depending on the BI type.

The device uses photodiode-based fluorescence detection, operates at 100–240 VAC with 12 VDC conversion, has an 8-well capacity arranged in 2 banks of 4, employs factory calibration with no customer adjustment, and uses barcode scanning to apply appropriate algorithmic interpretation. All specifications—incubation temperature, voltage, test capacity, calibration method, incubation time, and result indication mechanism—are identical to the predicate device.

Not stated in this summary. The document references FDA guidance on 'Reduced Incubation Time for intended Celerity 5 HP Biological Indicators and Celerity 20 HP Biological Indicators' but does not cite specific ISO, IEC, or ASTM consensus standards.

The proposed device demonstrates substantial equivalence because it is identical in all intended uses, technological characteristics, and performance to the legally marketed predicate (K223715). Both devices incubate and read the same Celerity BIs using the same fluorescence detection principle, temperature range, and operational workflow. Performance testing showed ≥97% alignment with 7-day reference methods and proper barcode recognition, confirming the device performs as safely and effectively as the predicate with no material differences in design, materials, or function.