# K103000: Smart Read Biological Test Pack

- Pathway: 510(k) (Special)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Feb 11, 2011 after 126 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 minutes or longer at 1320C (270'F) in pre-vacuum steam sterilizers. The test pack consists of a self-contained biological indicator containing Geobacillus stearothermoptiilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST7S. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.

Source page: https://510kreport.com/device/K103000
Methodology: https://510kreport.com/methodology