(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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Adolph E. D'Amico ·President Alden Scientific, Incorporated 360 Cold Spring Avenu 01089 Springfield, Massachusetts
JAN - 9 1998
Re : K971888 Trade Name: Glutatect Regulatory Class: II JOJ Product Code: December 11, 1997 Dated: December 16, 1997 Received:
Dear Mr. D'Amico:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. D'Amico
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Direct dr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): K971888 (Glutatect)
Device Name: Glutatect
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Qhin S. Lim
(Division Sign-Om)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K971888
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use X
§ 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).