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The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.

Device Description

The Browne Rapicide Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a structured study demonstrating the device's performance against them. The document is a 510(k) summary for a glutaraldehyde indicator, focusing on its substantial equivalence to a predicate device, intended use, and general product description.

However, based on the intended use described, we can infer the primary performance characteristic that would be subject to acceptance criteria: accuracy in determining if the glutaraldehyde concentration is above 1.5%.

Let's try to extract relevant information and identify what is missing for a complete answer based on your request.

Inferred Acceptance Criteria and Reported Device Performance (Table):

Acceptance Criterion (Inferred from Intended Use)	Reported Device Performance (Based on provided text)
Accurately indicate when glutaraldehyde concentration is ≥ 1.5% (Minimum Recommended Concentration - MRC).	The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%. Essentially, the claim is made that it performs this function, but the specific data from a study proving this accuracy (e.g., sensitivity, specificity, PPV, NPV) with numerical results is not provided in this document.
Accurately indicate when glutaraldehyde concentration is 1.5%), it does not provide the specific performance data, study design, sample sizes, ground truth establishment methods, or expert qualifications that would comprehensively answer your request regarding acceptance criteria and their proof. It focuses on regulatory substantial equivalence rather than a detailed scientific study report.

Acceptance Criterion (Inferred from Intended Use)

Reported Device Performance (Based on provided text)

Accurately indicate when glutaraldehyde concentration is ≥ 1.5% (Minimum Recommended Concentration - MRC).

The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%. Essentially, the claim is made that it performs this function, but the specific data from a study proving this accuracy (e.g., sensitivity, specificity, PPV, NPV) with numerical results is not provided in this document.

Accurately indicate when glutaraldehyde concentration is 1.5%), it does not provide the specific performance data, study design, sample sizes, ground truth establishment methods, or expert qualifications that would comprehensively answer your request regarding acceptance criteria and their proof. It focuses on regulatory substantial equivalence rather than a detailed scientific study report.

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