(37 days)
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration (MEC) of 0.6% glutaraldehyde.
The Browne Sporicidin Glutaraldehyde Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehydecontaining germicide solutions. The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.
The Browne Sporicidin Glutaraldehyde Indicator consists of a polypropylene strip with an indicator pad on one end. The indicator pad is impregnated with an indicator solution which changes color from tan to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 0.6%.
The Browne Sporicidin Glutaraldehyde Indicator and the predicate device have a 2-year shelf life from the date of manufacture in the unopened bottle. Containers of both devices have a 90 day in-use life.
Here's a breakdown of the acceptance criteria and the study details for the Browne Sporicidin Glutaraldehyde Indicator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes expected color changes at certain glutaraldehyde concentrations and the device's performance in terms of avoiding false positives and managing false negatives.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Positive Indicator (≥0.7% Glutaraldehyde): Uniform purple color within 1-2 minutes. | At 60 seconds (1 minute), the strip will exhibit a uniform purple color (except for the top 2 mm of the strip) if the concentration of glutaraldehyde is ≥0.7%. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time. |
| **Below Minimum Effective Concentration ( |
§ 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).