RAPICIDE OPA-28 TEST STRIP

K120652 · Serim Research Corp. · JOJ · Oct 12, 2012 · General Hospital

Device Facts

• Record ID: K120652
• Device Name: RAPICIDE OPA-28 TEST STRIP
• Applicant: Serim Research Corp.
• Product Code: JOJ · General Hospital
• Decision Date: Oct 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.

Device Story

The RAPICIDE OPA-28 Test Strip is a qualitative, single-use chemical indicator designed to monitor the potency of ortho-phthalaldehyde (OPA) disinfectant solutions. The device consists of a 0.40-inch square reagent-treated indicator pad affixed to a white opaque polystyrene strip. Operation involves dipping the test strip into the disinfectant solution; a two-step chemical reaction occurs where OPA first reacts to form a colorless product, followed by a second reaction with excess OPA to produce a green-colored compound. The resulting color change allows the user to visually determine if the OPA concentration is above or below the 0.35% MRC. It is intended for use in clinical settings where OPA-based high-level disinfection is performed. The device provides a simple, rapid method for healthcare providers to verify the efficacy of the disinfectant solution prior to use, ensuring patient safety by confirming the solution meets the required concentration for effective disinfection.

Clinical Evidence

No clinical data. Performance was evaluated via non-clinical bench testing, including shelf life, open bottle stability, and the effects of contaminants, temperature, and pH deviations. Analytical performance was verified by comparing test results in OPA solutions at the MRC and above against the predicate device.

Technological Characteristics

Qualitative chemical indicator strip; 0.4" x 0.4" reagent-treated pad on a 3.25" x 0.4" polystyrene strip. Principle: two-step chemical reaction resulting in a green color change. Detects OPA concentration relative to 0.35% MRC. Single-use, manual visual interpretation.

Indications for Use

Indicated for use by healthcare personnel to determine if the concentration of ortho-phthalaldehyde (OPA) in RAPICIDE OPA-28 disinfectant solution is above or below the 0.35% Minimum Recommended Concentration (MRC).

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

• Serim® DISINTEK™ OPA Test Strips (K081370)

Submission Summary (Full Text)

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SERIM Research Corporation 510(k) Premarket Notification RAPICIDE OPA-28 Test Strip

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14120652

# 510(K) SUMMARY

OCT 12 2012

| Prepared: | February 27, 2012 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | RAPICIDE OPA-28 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 RAPICIDE OPA-28 Test Strip is substantially<br>equivalent to Serim® DISINTEK™ OPA Test Strips, Serim<br>Research Corporation, P/N 5121; K081370. |
| Device Description: | The device is a qualitative, single use, reagent test strip<br>made up of a 0.40 inch square indicator pad that has been<br>chemically treated to detect OPA. 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 RAPICIDE OPA-28 Test Strip is a chemical indicator<br>for use in determining whether the concentration of ortho-<br>phthalaldehyde, the active ingredient in RAPICIDE OPA-<br>28 Solution, is above or below the established Minimum<br>Recommended Concentration (MRC) of 0.35%. |

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## Technological Characteristics:

The RAPICIDE OPA-28 Test Strip 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 reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA in excess 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-MRC-of-0.35%-OPA .- -

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#### Performance:

The performance of the RAPICIDE OPA-28 Test Strips was evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies and compared to test results obtained with Serim® DISINTEKTM OPA Test Strips evaluated in Cidex OPA solutions at the MEC and above as well. The performance of the RAPICIDE OPA-28 Test Strips is substantially equivalent to the predicate device, Serim® DISINTEK™ OPA Test Strips.

### Summary of Non-clinical Testing

The following table summarizes the non-clinical testing performed to demonstrate that the Rapicide OPA-28 Test strip is safe and effective in monitoring the OPA concentration in Rapicide OPA-28 Disinfectant Solution.

| Study | Result |
|---------------------------------|--------|
| Shelf Life | Passed |
| Open Bottle Stability | Passed |
| Effect of Contaminants | Passed |
| Effect of Temperature Deviation | Passed |
| Effect of pH Deviation | Passed |
| Analytical Specificity | Passed |

The RAPICIDE OPA-28 Test Strips have the same Conclusion: intended use as the predicate device. Both test strips measure the potency of ortho-phthalaldehyde (OPA) in disinfectant solution, to determine whether it is above or Recommended the Minimum or Effective below Concentration. The difference between the proposed OPA indicator and the predicate device is its use with a different OPA based disinfectant. We are adding a new indication for use to the predicate device, namely the use in the RAPICIDE OPA-28 solution. This difference does 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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

**OCT** 12 2012

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

Re: K120652

Trade/Device Name: Rapicide OPA-28 Test Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: October 2, 2012 Received: October 4, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. 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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K12 0652

**CONFIDENTIAL**

SERIM Research Corporation 510(k) Premarket Notification RAPICIDE OPA-28 Test Strip

### INDICATIONS FOR USE

510(k) Number (if known): K

RAPICIDE OPA-28 Test Strips Device Name:

Indications For Use: The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the ... the ... concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.

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)

Elizabeth F. Clamton Will

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

510(k) Number:

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