GLUTATECT

K971888 · Alden Scientific, Inc. · JOJ · Jan 9, 1998 · General Hospital

Device Facts

• Record ID: K971888
• Device Name: GLUTATECT
• Applicant: Alden Scientific, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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.

Device Story

Glutatect is a chemical indicator strip used to verify the concentration of glutaraldehyde in liquid chemical germicides. The device is used by healthcare personnel or end-users to ensure that germicide solutions (Procide, Cidex, Metricide brands) maintain sufficient active ingredient levels for effective disinfection. The user dips the indicator into the germicide solution; a chemical reaction produces a visual color change. The user compares this color against a reference chart to determine if the glutaraldehyde concentration is adequate. This provides immediate feedback on the efficacy of the germicide solution, helping to ensure proper disinfection protocols and patient safety by preventing the use of sub-potent germicides.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical indicator strip; colorimetric reaction principle; detects glutaraldehyde concentration in liquid germicides; standalone, non-electronic device.

Indications for Use

Indicated for use as a chemical indicator to measure the concentration of glutaraldehyde in specific liquid chemical germicides (Procide, Procide Plus, Procide NS, Cidex, Cidex Plus, Metricide, Metricide 28, and Metricide 30). Intended for over-the-counter use.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Qhin S. Lim

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(Division Sign-Om)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K971888

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use X

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