(69 days)
No
The device is a chemical indicator strip that changes color based on a chemical reaction, not through computational analysis or learning. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a glutaraldehyde concentration monitor for germicide solutions, not a device used to treat or diagnose a disease in a patient.
No
Explanation: The device is a "glutaraldehyde concentration monitor" for germicide solutions, not a diagnostic device for medical conditions or diseases. It monitors the chemical concentration of a solution, not a biological state.
No
The device is a chemical indicator strip, which is a physical component designed to change color based on chemical concentration. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the concentration of glutaraldehyde in germicide solutions. This is a quality control or monitoring function for a chemical disinfectant, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is a chemical indicator strip that changes color based on the concentration of glutaraldehyde in a solution. It does not interact with or analyze biological specimens.
- Lack of Biological Sample: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. This device tests a chemical solution.
- No Mention of Patient or Diagnosis: The text does not mention any patient, diagnosis, or medical condition that the device is used to assess.
Therefore, the Browne Metrex 1.8% Glutaraldehyde Indicator is a chemical indicator used for quality control of a disinfectant solution, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Metricide Plus 300 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.
Product codes
JOJ
Device Description
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and The Drownload Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehyde-containing germicide solutions. The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.
The Browne Metrex 1.8% Glutaraldehyde Indicator consists of a polypropylene The Drowns 110ward results of pad on one end. The indicator pad is impregnated with an indicator solution that changes color from yellow to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 1.8%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performance characteristics of the Browne Metrex 1.8% Glutaraldehyde Indicator were established by testing indicators in Metricide 28 and Metricide Plus 30 Solutions containing 1.8% and 2.1% glutaraldehyde. No false positives were recorded in solutions containing 1.8% glutaraldehyde, when the testing was performed according to the Instructions for Use. The data demonstrates that the Browne Metrex 1.8% Glutaraldehyde Indicator is an effective monitor for the glutaraldehyde component of the Metricide 28 and Metricide Plus 30 Solution with a glutaraldehyde MEC of 1.8%.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
K 012335
510(k) Summary
for
Browne Metrex 1.8% Glutaraldehyde Indicator for METRICIDE® 28 and METRICIDE PLUS 30° Solutions
SUBMITTER NAME AND ADDRESS 1.
Mr. Alan Charlton Albert Browne Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
Alan Charlton Contact: 44 116 276 8636 Telephone number:
2. DEVICE NAME
| Proprietary Name: | Browne Metrex 1.8% Glutaraldehyde Indicator for
Metricide® 28 and Metricide Plus 30® Solutions |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Browne Metrex 1.8% Glutaraldehyde Indicator |
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
3. PREDICATE DEVICE
Browne GA Indicator (K922481, Albert Browne Ltd.)
4. INTENDED USE
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solution (Browne Metrex 1.8% Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration (MEC) of 1.8% glutaraldehyde.
The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide 28 and Metricide Plus 30 Solutions.
1
DEVICE DESCRIPTION ડ.
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and The Drownload Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehyde-containing germicide solutions.` The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.
The Browne Metrex 1.8% Glutaraldehyde Indicator consists of a polypropylene The Drowns 110ward results of pad on one end. The indicator pad is impregnated with an indicator solution that changes color from yellow to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 1.8%.
TECHNOLOGICAL CHARACTERISTICS 6.
The technological characteristics of the Browne GA Indicator are similar to that of the Browne Metrex 1.8% Glutaraldehyde Indicator described in this Both devices are non-sterile, disposable strips containing an submission. indicator pad impregnated with an indicator solution that changes color in a germicide solution at the appropriate glutaraldehyde concentration.
The mechanism of action for inducing a color change is identical for the Browne 1.8% Glutaraldehyde Indicator and the Browne GA Indicator. Metrex Medex 11070 reacts with sodium sulfite in the test strip to form a sulfite addition product and an equivalent amount of base. If sufficient glutaraldehyde is present, the increase in pH causes a color change in the pH indicator.
The indicator color is dependent upon the glutaraldehyde concentration of the germicide solution, and the time after exposure when the results of the test are read, as described in the table below.
| Time(minutes) | Glutaraldehyde Concentration (%) | ||
|---|---|---|---|
| 2.1 | |||
| 2 | yellow, purple/yellow |
Color Development for the Metrex 1.8% Glutaraldehyde Indicator Strip
2
During the first 60 seconds after the test strip has been dipped into the Metricide 28 or Metricide Plus 30 Solution, the yellow test strip will begin to develop a purple color.
At 60 seconds (one minute), the strip will exhibit a uniform purple color (except for the top 2 mm of the strip) if the concentration of glutaraldehyde is >2.1. The strip will appear patchy purple/yellow or yellow if the solution contains