(233 days)
Glutatect is a chemical indicator for liquid chemical germicides when used according to the Directions For Use. Glutatect is used to measure the active ingredient in the germicide solution. The liguid chemical germicides are Procide, Procide Plus, Procide NS, Cidex, Cidex Plus, Metricide, Metricide 28 and Metricide 30. The active ingredient in the germicide solution is glutaraldehyde.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Glutatect." This type of document confirms that a new medical device is substantially equivalent to a legally marketed predicate device, but it does not contain the detailed study information typically found in a clinical trial report or a performance study summary.
Therefore,Based on the provided text, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them because this document is a 510(k) clearance letter and does not include performance study details.
Here's why and what kind of information is present:
- What this document is: A letter from the FDA stating that Glutatect is substantially equivalent to existing devices and can be marketed. It confirms the regulatory class (II), product code, and indications for use.
- What this document is not: A clinical study report, a performance evaluation summary, or a direct explanation of the acceptance criteria and corresponding study results. These details would typically be submitted to the FDA as part of the 510(k) application, but they are not detailed in the clearance letter itself.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details. This information is simply not in this document.
§ 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).