# K182931: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

- Pathway: 510(k) (Special)
- Applicant: Steris Corporations
- Decided: Nov 20, 2018 after 29 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K133267 (2014). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173633: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag, STERIS Corporation (2018) Summary page 6.

## Most influential descendants
- K243501: 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 (2025), 0 descendants of its own

## Indications for use
The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134°C for 3.5 minutes with a 2 minute dry time. VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list. • 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company • 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company • Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc. • Celerity 20 Steam Biological Indicator • VERIFY STEAM Integrating Indicator • VERIFY SixCess MF4 STEAM Emulating Indicator VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator. The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Read Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack. The VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10-minute 270°F/132°C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

Source page: https://510kreport.com/device/K182931
Methodology: https://510kreport.com/methodology