(233 days)
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No
The summary describes a chemical indicator for germicides, which is a passive device and does not mention any computational or learning capabilities.
No
This device is a chemical indicator used to measure the active ingredient in germicide solutions, not a device intended to treat or manage a medical condition.
No
Glutatect is described as a chemical indicator used to measure the active ingredient in germicide solutions, not to diagnose a medical condition in a patient.
No
The device is described as a "chemical indicator" for liquid chemical germicides, which strongly suggests a physical component (like a test strip or solution) is involved in the measurement of the active ingredient. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Glutatect is a "chemical indicator for liquid chemical germicides" used to "measure the active ingredient in the germicide solution."
- Function: Its function is to test the concentration of a chemical (glutaraldehyde) in a solution used for disinfection, not to diagnose a disease or condition in a human or animal.
- Lack of Biological Sample: IVDs typically involve testing biological samples (blood, urine, tissue, etc.) from a patient. This device tests a chemical solution.
Therefore, Glutatect falls under the category of a chemical indicator or a test for chemical solutions, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
JOJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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
1
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
2
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