SERIM DISINTEK GTA 2.1%, MODEL: 5164

K083295 · Serim Research Corp. · JOJ · Mar 16, 2009 · General Hospital

Device Facts

• Record ID: K083295
• Device Name: SERIM DISINTEK GTA 2.1%, MODEL: 5164
• Applicant: Serim Research Corp.
• Product Code: JOJ · General Hospital
• Decision Date: Mar 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution

Device Story

Single-use, qualitative reagent test strip; 0.4-inch square reagent pad on 3.25-inch polystyrene strip. Used to verify potency of CIDEXPLUS 28 Day glutaraldehyde disinfectant solutions. Principle: chemical reaction between glutaraldehyde, sodium sulfite, and sodium bisulfite; base production triggers pH indicator color change. Above 2.1% MEC: solid purple color. At/near MEC: blotched yellow/purple. Below 1.5%: yellow. Visual interpretation via comparison to color block. Assists healthcare providers in ensuring disinfectant efficacy before instrument processing; ensures patient safety by confirming adequate sterilization/disinfection levels.

Clinical Evidence

Bench testing only. Performance evaluated via split-sample blind studies comparing Serim DISINTEK GTA 2.1% Test Strips to predicate CIDEXPLUS Solution Test Strips. Results demonstrate substantial equivalence in determining glutaraldehyde concentration relative to the 2.1% MEC.

Technological Characteristics

Reagent test strip; 0.4-inch square pad on 3.25-inch x 0.4-inch white opaque polystyrene strip. Chemical sensing principle: glutaraldehyde reacts with sodium sulfite to form base; base reacts with pH indicator. Contains sodium bisulfite for neutralization control. Visual colorimetric output.

Indications for Use

Indicated for determining if glutaraldehyde concentration in CIDEXPLUS 28 Day Solution is above or below the 2.1% minimum effective concentration (MEC).

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.

Predicate Devices

• CIDEXPLUS Solution test strips (K981054)

Submission Summary (Full Text)

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SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%

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**CONFIDENTIAL**

K083295

# 510 (K) SUMMARY

MAR 1 6 2009

| Prepared: | November 6, 2008 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Serim Research Corporation |
| Address | P.O. Box 4002<br>Elkhart IN 46514 |
| Phone:<br>Fax: | 574-264-3440<br>574-266-6222 |
| Contact: | Patricia A. Rupchock<br>Director of Regulatory Affairs |
| Device Trade Name: | Serim® DISINTEK™ GTA 2.1% |
| Common or Usual Name: | Indicator for CIDEXPLUS glutaraldehyde disinfectant<br>solutions. |
| Device Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Product Code: | JOJ |
| Class: | II |
| Regulation Number: | 21CFR 880.2800 |
| Substantial Equivalence: | The Serim® DISINTEK™ GTA 2.1% is substantially<br>equivalent to CIDEXPLUS Solution test strips ; K981054 |
| Device Description: | The device is a qualitative, single use, reagent test strip<br>made up of a 0.40-inch square reagent pad that has been<br>chemically treated to detect glutaraldehyde in<br>CIDEXPLUS 28 Day solutions. The pad is affixed to one<br>end of a 3.25 inch by 0.40-inch white opaque polystyrene<br>strip. |
| Intended Use: | The Serim® Disintek GTA 2.1% Test Strip is a chemical<br>indicator for use in determining whether the concentration<br>of glutaraldehyde the active ingredient in CIDEXPLUS<br>28 Day Solution, is above or below the minimum<br>effective concentration (MEC) established for<br>CIDEXPLUS 28 Day Solution |

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SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%

> The Serim® Disintek GTA 2.1% Test Strips contain three Technological Characteristics: reacting chemicals, and a background dye. The visual response given by the indicator pad of the test strip is based on the following chemical reactions. Glutaraldehyde reacts with sodium sulfite to form a colorless addition product and a base. The base then reacts with a pH indicator producing a purple color. The indicator pad also contains sodium bisulfite, which reacts with both glutaraldehyde and with the base. When glutaraldehyde concentration is above the 2.1% level (MEC), enough base is produced to result in an irreversible and distinct color change of the indicator pad. Testing of freshly activated Cidex® Plus solutions always results in a solid purple color on the indicator pad. When the glutaraldehyde concentration is at or approaching the MEC level, the base is neutralized by the sodium bisulfite and the indicator pad will display a distinctly blotched yellow and purple appearance. The test pad size of 0.4" x 0.4" and a color block showing a representative color change for the MEC level allows for easy interpretation of the change in color. As the glutaraldehyde concentration approaches 1.5%, the indicator pad will appear mostly yellow. The device will reliably indicate if the glutaraldehyde concentration is above or below the MEC level of 2.1% in CIDEXPLUS 28 Day solutions. The performance of the Serim Disintek GTA 2.1% Test Performance: Strips was evaluated in split samples blind studies and compared to test results obtained with CIDEXPLUS Solution Test Strips. The performance of the Serim Disintek GTA 2.1% Test Strips is substantially equivalent to the predicate device, CIDEXPLUS Solution Test Strips. Conclusion: The Serim Disintek GTA 2.1% Test Strips have the same intended use as the predicate device. Both test strips measure the potency of GTA in CIDEXPLUS 28 Day Solution, above or below the Minimum Effective Concentration of 2.1%. The Serim Disintek GTA 2.1% Test Strips do not raise any new safety or effectiveness issues.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized eagle with three overlapping wings, representing health, services, and people. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

MAR 1 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Drive Elkhart, Indiana 46514

Re: K083295

> Trade/Device Name: Scrim® DISINTEK™ GTA 2.1% Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 23, 2009 Received: February 26, 2009

Dear Ms. Rupchock:

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.

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Page 2 - Ms. Rupchock

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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sutte y. Michael Davis.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Serim® DISINTEK™ GTA 2.1%

Indications For Use: The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.

K

Prescription Use Over-The-Counter Use AND / OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shala A Murphy, MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083245

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