# K092346: Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Jan 7, 2010 after 156 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
Longest line of descent: 1 generation back to K915170 (1992). 1 ancestor in all.
2 later devices descend 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)
- K915170: Pymah Cold Sterilog Glutaraldehyde Monitor, Pymah Corp. (1992) Summary page 1.

## Most influential descendants
- K103126: Trophon Chemical Indicator (2011), 1 descendant of its own
- K233413: Ultraphon Chemical Indicator (TRO-T and TRO-B) (2024), 0 descendants of its own

## Indications for use
The Serim®&D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.

Source page: https://510kreport.com/device/K092346
Methodology: https://510kreport.com/methodology