3M Company · Class II · Cleared Jan 28, 2025
| K-number | K243501 |
| Device name | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M |
| Applicant | 3M Company |
| Product code | FRC |
| Device class | Class II |
| Decision date | Jan 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.2800 |
The 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE is a single-use biological indicator process challenge device designed to qualify and monitor steam sterilization cycles at 270°F (132°C) for 10 minutes in healthcare facilities. It contains a biological indicator (1492V) and chemical integrator, and must be used with the 3M Attest Auto-reader 490, 490H (software 4.0.0+), or 490M to detect sterilization process failures through fluorescence detection at 24 minutes.
The submission device uses a clear plastic shell with a tortuous channel sealed by foil lid (single-use), whereas the predicate uses a reusable aluminum tube with removable plug. Both contain Geobacillus stearothermophilus biological indicators (≥10⁶ spores) with equivalent D-values and survival/kill times meeting FDA and ISO 11138-3 requirements. The submission's chemical indicator is a Type 5 moving-front integrator; the predicate uses a Type 6 emulating indicator. Both include a visible color-change process indicator to distinguish processed from unprocessed packs.
FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007); ANSI/AAMI ST79:2017 (Comprehensive guide to steam sterilization and sterility assurance); ASTM F88/F88M-15 (Seal Strength of Flexible Barrier); ASTM F2824-10 (Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids); ISO 11138-1:2017.
Both devices serve identical intended uses as single-use biological indicator process challenge devices for monitoring 10-minute 270°F (132°C) dynamic-air-removal steam sterilization cycles. Performance testing demonstrated that the 1492PCDE challenge pack provides equivalent or greater resistance compared to both the AAMI 16 Towel PCD reference standard and standalone indicators, and that the contained 1492V biological indicator (previously cleared per K241710) performs equivalently to the predicate's Celerity 20 STEAM indicator. Both utilize fluorescence-based detection with an incubator/reader system and contain chemical indicators that independently monitor all critical sterilization parameters. The differences in materials (clear plastic vs. aluminum) and chemical integrator types do not alter the fundamental performance or safety of the device.
View the full FDA submission: accessdata.fda.gov