SULTAN SPOROX TEST VIAL, MODEL 75195

K020612 · Sultan Chemists, Inc. · JOJ · May 7, 2002 · General Hospital

Device Facts

• Record ID: K020612
• Device Name: SULTAN SPOROX TEST VIAL, MODEL 75195
• Applicant: Sultan Chemists, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization..

Device Story

Sultan Sporox Test Vial (Model 75195) serves as a chemical indicator for verifying hydrogen peroxide concentration in Sporox Sterilizing and Disinfecting Solution. Used in clinical or dental settings by healthcare personnel to ensure the chemical solution maintains required potency for high-level disinfection. The device provides a qualitative visual result; it does not measure sterilization or disinfection outcomes directly. Users compare the test result against established concentration thresholds to determine if the solution remains effective for use. This ensures the chemical agent is active, supporting proper infection control protocols and patient safety.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Qualitative chemical indicator vial. Designed for detection of hydrogen peroxide concentration in liquid chemical sterilants. Class II device (Product Codes: JOJ, MED).

Indications for Use

Indicated for use as a rapid, qualitative method to verify effective hydrogen peroxide concentration in Sporox Sterilizing and Disinfecting Solution. Not for confirmation of disinfection or sterilization efficacy.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

MAY 0 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Clark Smith Vice President Sultan Chemists, Incorporated 85 West Forest Avenue Englewood, New Jersey 07631

Re: K020612

Trade/Device Name: Sultan Sporox Test Vial, Model 75195 Regulation Number: 880.2800 and 880.6885 Regulation Name: Sterilization Process Indicator and Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: II Product Code: JOJ and MED Dated: February 20, 2002 Received: February 25, 2002

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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## Page 2 - Mr. Smith

of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Statement of Indications For Use

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## K020612 510(k) Number: __

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization..

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use __

Qitu S. Lin

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

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