# K012335: Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Oct 1, 2001 after 69 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 K922481 (1994). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922481: Browne GA Indicator Use in 2% Activ Glutaraldehyde, Board of Directors, Albert Browne, Ltd. (1994) Summary page 1.

## Most influential descendants
- K081600: Steris Resert XL Test Strip (2008), 8 descendants of its own
- K102217: System 1E Chemical Indicator (2010), 5 descendants of its own
- K173428: VERIFY Chemical Indicator for S40 Sterilant (2018), 3 descendants of its own
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS (2024), 1 descendant of its own
- K102296: Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2) (2011), 1 descendant of its own

## Indications for use
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Metricide Plus 30 Solutions (Browne Metrex 1.8% Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 1.8% glutaraldehyde. The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide® 28 and Metricide Plus 30® Solutions.

Source page: https://510kreport.com/device/K012335
Methodology: https://510kreport.com/methodology