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According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

The CytoQuant™ Chlamydia Transport Medium (2SP) is widely recognized as an effective medium for chlamydia transport

This document does not contain the requested information regarding the acceptance criteria and a detailed study proving the device meets those criteria. The provided text primarily focuses on safety precautions for handling the Chlamydia Transport Medium and states that "Proteins International conducts its own studies on each lot... using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain chlamydia viability over time." However, it does not provide the specific acceptance criteria for these characteristics, nor does it detail a study with the results of device performance against such criteria. The references cited are general and do not appear to be specific to a study validating this particular device.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory.

This document does not contain the information required to complete the request. The provided text is a "Safety & Effectiveness Summary" for a Viral Transport Medium, which focuses on regulatory classification, safety precautions for handling the product, and general statements about its effectiveness based on published literature and internal quality control.

Here's why the specific questions cannot be answered from the provided text:

• Acceptance Criteria and Reported Device Performance (Table): The document states "Proteins International conducts its own studies on each lot of Viral Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain virus viability over time." However, it does not provide specific numerical acceptance criteria for these attributes (e.g., "maintain virus viability for X hours at Y temperature with Z% recovery") nor does it report the specific performance results against these criteria for any particular study. It only states that "Complete study results for each lot are available on request."
• Sample Size (Test Set), Data Provenance: No details about a specific test set, its sample size, or data provenance (e.g., country, retrospective/prospective) are mentioned.
• Number of Experts, Qualifications: Not applicable as no expert-based ground truth establishment is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No mention of a multi-reader, multi-case study comparing human readers with and without AI assistance.
• Standalone Performance: No standalone algorithm performance is described as this is a physical medical device (viral transport medium), not an AI algorithm.
• Type of Ground Truth: The "effectiveness" mentioned refers to maintaining virus viability, which implies laboratory assays rather than expert consensus, pathology, or outcomes data in the context of an AI device.
• Sample Size (Training Set): No training set information is applicable or provided, as this is not an AI/machine learning device.
• Ground Truth (Training Set): Not applicable for the same reason.

In summary, the document describes a viral transport medium and its general safety and effectiveness, but it does not detail a specific study with acceptance criteria and results in a format applicable to evaluating a diagnostic device or AI algorithm's performance. It refers to internal quality control studies for each manufacturing lot, but doesn't provide the specifics of those studies.

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