SERIM DISINTEK OPA TEST STRIP

K081370 · Serim Research Corp. · JOJ · Jul 11, 2008 · General Hospital

Device Facts

• Record ID: K081370
• Device Name: SERIM DISINTEK OPA TEST STRIP
• Applicant: Serim Research Corp.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Serim ® DISINTEK ™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex ® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.

Device Story

The Serim DISINTEK OPA Test Strip is a qualitative, single-use chemical indicator used to verify the potency of Cidex OPA Solution. The device consists of a 0.40-inch square chemically treated test pad affixed to a 3.25-inch white opaque polystyrene strip. The user dips the test strip into the OPA solution; a two-step chemical reaction occurs. First, OPA at concentrations up to 0.3% reacts to form a colorless product. Second, OPA levels above 0.3% react with a second chemical to produce a green color. The presence or absence of this green color allows the clinician to determine if the solution is above or below the MEC. This provides a rapid visual assessment of disinfectant efficacy, ensuring the solution remains potent for high-level disinfection processes.

Clinical Evidence

Bench testing only. Performance was evaluated using split-sample blind studies comparing the Serim DISINTEK OPA Test Strips to the predicate Cidex OPA Solution Test Strips. No clinical data was required or presented.

Technological Characteristics

Qualitative chemical indicator strip. Materials: 0.4" x 0.4" chemically treated test pad on a 3.25" x 0.4" white opaque polystyrene strip. Sensing principle: Two-step chemical reaction (colorimetric). Detects OPA concentration relative to 0.3% MEC. Single-use. No software or electronic components.

Indications for Use

Indicated for determining if ortho-phthalaldehyde (OPA) concentration in Cidex OPA Solution is above or below the 0.3% 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

• Cidex ® OPA Solution Test Strip (K991709)

Submission Summary (Full Text)

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Ko81370

## 510 (K) SUMMARY

| Prepared: | May 9, 2008 | JUL 11 2008 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter: | Serim Research Corporation | |
| Address | P.O. Box 4002<br>Elkhart IN 46514 | |
| Phone: | 574-264-3440 | |
| Fax: | 574-266-6222 | |
| Contact: | Patricia A. Rupchock<br>Director of Regulatory Affairs | |
| Device Trade Name: | Serim ^® DISINTEK ^™ OPA Test Strips | |
| Common or Usual Name: | Indicator for ortho-phthalaldehyde (OPA) high level<br>disinfectant | |
| Device Classification Name: | Chemical Indicators for Liquid Chemical Germicide. (b)<br>Class II (Physical/Chemical Sterilization Process<br>Indicator). | |
| Product Code: | JOJ | |
| Class: | II | |
| Regulation Number: | 21CFR 880.2800 | |
| Substantial Equivalence: | The Serim DISINTEK OPA Test Strip is substantially<br>equivalent to Cidex ^® OPA Solution Test Strip; K991709. | |
| Device Description: | The device is a qualitative, single use, reagent test strip<br>made up of a 0.40 inch square test pad that has been<br>chemically treated to detect OPA in Cidex OPA Solution.<br>The pad is affixed to one end of a 3.25 inch by 0.40 inch<br>white opaque polystyrene strip. | |
| Intended Use: | The Serim ^® DISINTEK ^™ OPA Test Strip is a chemical<br>indicator for use in determining whether the concentration<br>of ortho-phthalaldehyde, the active ingredient in Cidex ^®<br>OPA Solution, is above or below the minimum effective<br>concentration (MEC) established for Cidex OPA Solution. | |

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## SERIM Research Corporation 510(k) Premarket Notification Serim® DISINTEK™ OPA Test Strip

Technological Characteristics: The Serim DISINTEK OPA Test Strips contains two reacting chemicals, a stabilizer, and other non-reacting ingredients. The reaction process involved with the test strip is based on a two step reaction. The first step involves a reaction in which a chemical at a concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color. The test pad size of 0.4" x 0.4" allows for easy interpretation of the change in color. The device will reliably indicate if the OPA concentration is above or below the MEC level of 0.3% OPA.

- The performance of the Serim DISINTEK OPA Test Strips Performance: was evaluated in split samples blind studies and compared to test results obtained with Cidex OPA Solution Test Strips. The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Cidex OPA Solution Test Strips.
- Conclusion: The Serim DISINTEK OPA Test Strips have the same intended use as the predicate device. Both test strips measure the potency of OPA in Cidex OPA Solution, above or below the Minimum Effective Concentration of 0.3%. The Serim DISINTEK OPA 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

JUL 11 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Street Elkhart, Indiana 46561

Re: K081370

Trade/Device Name: Serim® DISINTEKTM OPA Test Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Physical/Chemical Sterilization Process Regulatory Class: Class II Product Code: JOJ Dated: May 9, 2008 Received: May 15, 2008

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 (OS) 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 (240) 276-{See Below For Phone Numbers]. 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 yours,

Clare

Chiu Lin, Ph.D. 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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## INDICATIONS FOR USE

K 08/020 510(k) Number (if known):

Serim® DISINTEK™ OPA Test Strips Device Name:

Indications For Use: The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.

Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (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)

Shula H Murphy, R

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

510(k) Number: 081372