# K083295: Serim Disintek Gta 2.1%, Model: 5164

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Mar 16, 2009 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
Longest line of descent: 2 generations back to K924681 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981054: Browne GA Indicator for Cidex Products, Albert Browne, Ltd. (1998) Summary page 1.

## Indications for use
The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.

Source page: https://510kreport.com/device/K083295
Methodology: https://510kreport.com/methodology