CIDEX OPA SOLUTION TEST STRIP

K992341 · Serim Research Corp. · JOJ · Nov 23, 1999 · General Hospital

Device Facts

• Record ID: K992341
• Device Name: CIDEX OPA SOLUTION TEST STRIP
• Applicant: Serim Research Corp.
• Product Code: JOJ · General Hospital
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

CIDEX® OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of OPA in CIDEX® OPA Solution is above or below the MEC. CIDEX® OPA Solution Test Strips cannot be used to validate the disinfection process.

Device Story

Device consists of 0.2-inch reagent-containing pad on 0.2 x 3.25-inch polystyrene handle. Used to test CIDEX® OPA Solution concentration. User immerses pad in sample for 30 seconds, waits 2.5 minutes, then compares pad color to standard color block. If pad color is equal to or darker than standard, OPA concentration is above MEC; if lighter, solution is ineffective. Used in clinical or laboratory settings by healthcare personnel. Provides visual pass/fail result to ensure disinfectant efficacy, preventing use of sub-therapeutic solutions.

Clinical Evidence

Bench testing only. Eight individuals, including three inexperienced in laboratory techniques, performed 324 tests per standard. At 0.30% OPA (MEC), 324/324 results were FAIL (1.00 specificity). At 0.40% and 0.45% OPA, 322/324 and 324/324 results were PASS, respectively.

Technological Characteristics

Chemical indicator strip; polystyrene handle; reagent-containing paper pad with chemical inhibitor. Visual colorimetric detection principle. Dimensions: 0.2 x 3.25 inches. No energy source. Standalone use.

Indications for Use

Indicated for semi-quantitative determination of ortho-phthalaldehyde (OPA) concentration in CIDEX® OPA Solution to verify if levels are above or below the 0.3% minimum effective concentration (MEC). Not for validation of disinfection or sterilization processes.

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® Solution Test Strips (K915170)

Submission Summary (Full Text)

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NOV 2 3 1999

K992341 page 1 of 2

Image /page/0/Picture/2 description: The image shows the logo for Serim Research Corp. The logo is black and white and features the word "Serim" in a large, bold font. Below the word "Serim" is the text "RESEARCH CORP" in a smaller font. The letters in "Serim" are connected, and there is a small "TM" symbol in the upper right corner of the logo.

P.O. Box 4002, Elkhart, IN 46514-0002 • [phone] • FAX [phone]

### 510(k) SUMMARY

## CIDEX® OPA Solution Test Strips

# SUBMITTED BY

James E. Christner Serim Research Corporation P.O. Box 4002 23565 Reedy Dr. Elkhart, IN 46514

| Phone: | [phone] |
|-----------------|----------------------|
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact Person: | James E. Christner |
| Date Prepared: | July 7, 1999 |

#### DEVICE NAME

| Trade Name: | CIDEX® OPA Solution Test Strips |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Test Strips for ortho-Phthalaldehyde (OPA) in CIDEX® OPA<br>Solution |
| Classification Name: | Chemical Sterilization Process Indicator |

### PREDICATE DEVICE

Cidex® Solution Test Strips (K915170)

# DESCRIPTION OF THE CIDEX® OPA SOLUTION TEST STRIP

The CIDEX® OPA Solution Test Strips consist of a 0.2-inch reagent-containing pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The indicator pad contains a color-forming reagent. It also contains an inhibiting compound that prevents visible reaction when the OPA concentration is at or below the MEC. When the OPA level is in sufficient excess of the MEC, the surplus reacts with the color-forming reagent.

The sample is placed in a 12 x 75-mm glass test tube. The indicator pad is immersed in the sample for 30 seconds, removed and allowed to react for an additional two and one-half

^{1 ®} Advanced Sterilization Products, a Johnson company, Division of Ethicon, Inc., Irvine, CA.

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K992341
Page 2 of 2

minutes at which time it is compared to a color standard. If the color of the entire pad is equal to or darker than the color standard, the concentration of ortho-phthalaldehyde (OPA) in CIDEX® OPA Solution is above the minimum effective concentration (MEC). If any part of the pad is lighter than the color standard, the CIDEX® OPA Solution should not be used.

### INTENDED USE

CIDEX® OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of OPA in CIDEX® OPA Solution is above or below the MEC. CIDEX® OPA Solution Test Strips cannot be used to validate the disinfection process.

# TECHNOLOGICAL COMPARISON TO THE PREDICATE DEVICE

CIDEX® OPA Solution Test Strips are used for determining OPA in CIDEX® OPA Solution whereas the CIDEX® Solution Test Strips are used for determining glutaraldehyde levels in CIDEX® Activated Dialdehyde Solution. Both tests have dry, reagent-containing paper indicator pads attached to plastic handles. Both pads contain an inhibitor that prevents reaction with an indicator at ineffective active ingredient concentrations.

The reaction pad of the CIDEX® OPA Solution Test Strips is observed three minutes after the strip is immersed in the solution while that of CIDEX® Solution Test Strips is read between five and eight minutes after immersion. For interpretation of the indicator pad of the CIDEX® OPA Solution Test Strip is compared with a standard color block. The CIDEX® Solution Test Strips use a visual standard for interpretation of the result.

# STATEMENT OF SUBSTANTIAL EQUIVALENCE

Eight individuals used CIDEX® OPA Solution Test Strips from three trial production lots in blind studies to test CIDEX® OPA Solution standards. Three of the readers were inexperienced in laboratory techniques. A total of 324 results were obtained with each standard.

At the MEC (0.30% OPA), 324 results were FAIL giving a specificity (lack of false PASS results) of 1.00. At 0.40% and 0.45% OPA, 322 and 324 results, respectively, were PASS. These results show that the CIDEX® OPA Solution Test Strips effectively indicate when the OPA concentration in CIDEX® OPA Solution is at the MEC of 0.3%.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the feathers.

Public Health Service

NOV 2 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James E. Christner Vice President, Research & Development Serim Research Corporation P.O. Box 4002 23565 Reedy Drive Elkhart, Indiana 46514

Re : K992341 CIDEX® OPA Solution Test Strips Trade Name: Requlatory Class: II Product Code: JOJ October 22, 1999 Dated: Received: October 26, 1999

Dear Mr. Christner:

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, Druq, 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 your 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Christner

obligation you might have under sections 531 through 542 of obligation you might have aha Electronic Product Radiation the Act for devices ander one Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis leccer will arrow your can be and fication. The FDA described in your from premation of your device to a legally Finding of Subscancear equired in a classification for your marketed predicate device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpos Part 801 and additionally 809.10 for in regulacion (si c devices), please contact the Office of VILID draghobere at [phone]. Additionally, for questions on Compriance at (501) sectising of your device, please contact che promocion and adversional [phone]. Also, please note the Orice Of Comprising wo entitled, "Misbranding by reference to the regulation chercred, "Microlaria" (21 CFR 807.97) der Other general information on your responsibilities under the Act may be Information on your ropportion of Small Manufacturers Assistance obcation from choman [phone] or [phone] or at at its corr free namber (s://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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K992341 510(k) Number (if known): __

Device Name: CIDEX* OPA Solution Test Strips

Indications For Use:

CIDEX* OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of active ingredient in CIDEX* OPA Solution is above or below the minimum CIDEX* OPA Solution Test effective concentration of 0.3% OPA. Strips cannot be used to validate the sterilization or disinfection process.

(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) ાવ

Over-The-Counter Use

(Optional Format 1-2-96)

sion Sign-Off

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

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