# K080136: Instant Readout Chemical Integrator Challenge Pack, Model LT- 105

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products, Inc.
- Decided: Aug 15, 2008 after 206 days
- Product code: JOJ (Indicator, Physical/Chemical 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103053: Verify 270FP Challenge Pack (2011), 1 descendant of its own
- K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (2017), 0 descendants of its own

## Indications for use
The SteriTec Instant Readout Chemical Integrator Challenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270 0 F) or 135°C (275 0 F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.

Source page: https://510kreport.com/device/K080136
Methodology: https://510kreport.com/methodology