BROWNE OPA TEST STRIP

K081427 · STERIS Corporation · JOJ · Jun 11, 2008 · General Hospital

Device Facts

• Record ID: K081427
• Device Name: BROWNE OPA TEST STRIP
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Browne OPA Test Strip is a concentration monitor for use in orthophthalaldehyde- containing germicide solutions with a minimum effective concentration of 0.3%.

Device Story

Browne OPA Test Strip is a single-use chemical indicator for monitoring ortho-phthalaldehyde (OPA) concentration in germicide solutions. Device consists of absorbent paper pad impregnated with reactive chemicals, bonded to polymer film. User dips strip into OPA solution for 1 second and reads color change after 60 seconds. Color shift from light blue to purple indicates whether OPA concentration remains above 0.3% minimum effective concentration. Used in clinical settings to verify germicide potency before instrument reprocessing. Provides immediate visual feedback to healthcare personnel, ensuring effective disinfection and patient safety.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use chemical indicator strip; absorbent paper pad with reactive chemicals on polymer film backing. Colorimetric sensing principle (blue to purple). Manual operation. No electronics or software.

Indications for Use

Indicated for monitoring ortho-phthalaldehyde concentration in Cidex™ OPA germicide solutions with a minimum effective concentration of 0.3%.

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

• Browne Cidex™ OPA Indicator (K991709)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "STERIS" in large, bold letters. Above the word "STERIS" is the number "K081427". To the right of the word "STERIS" is the text "P.1 of 2". Below the word "STERIS" is a graphic of several horizontal lines.

JUN 1 1 2008

# 510(k) Summary For Browne OPA Test Strip

Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom Phone: [phone] Fax No: [phone]

Contact: Richard Bancroft Development & Technical Service Director Telephone:[phone] Fax No: 011 44 116 2768639 Email: [e-mail]

Summary Date: May 19, 2008

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{1}------------------------------------------------

K081427
p.2 of 2

#### 1. Device Name

| Trade Name: | Browne OPA Test Strip |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/usual Name: | Browne OPA Test Strip |
| Classification Name: | Physical/chemical sterilization process indicator (21<br>CFR 880.2800 (b), Product Code JOJ). |

#### 2. Predicate Device

K991709 - Browne Cidex™ OPA Indicator.

#### 3. Description of Device

The Browne OPA Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne OPA Test Strip has been developed to monitor the active OPA concentration of Cidex™ OPA solution that has a concentration greater than 0.3% by way of a color change from light blue to purple.

#### 4. Intended Use

The Browne OPA Test Strip is a concentration monitor for use in orthophthalaldehyde- containing germicide solutions with a minimum effective concentration of 0.3%.

#### Description of Safety and Substantial Equivalence 5.

The proposed and predicate devices are all single use indicators used to monitor ortho-phthalaldehyde concentration in germicide solutions. The differences between the proposed Browne OPA Indicator and predicate devices are limited to differences in the dip/read time. The predicate device was cleared under K991709, for 1 second dip / 90 second read. The proposed device is to be dipped and read at 1 second (dip) / 60 second (read). These differences do not raise any new issues of safety and efficacy.

A summary of the technological characteristics of the new device in comparison to those of the predicate devices is provided in Section 12 of this premarket notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 1 1 2008

Mr. Richard Bancroft Senior Director, FDA Regulatory Affairs STERIS Corporation Chancery House, 190 Waterside Road Hamilton Industrial Park, Leicester, LE5 1QZ United Kingdom

Re: K081427

Trade/Device Name: Browne OPA Test Strip Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: May 20, 2008 Received: May 21, 2008

Dear Mr. Bancroft:

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.

{3}------------------------------------------------

### Page 2 -- Mr. Bancroft

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

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

{4}------------------------------------------------

## Indications for Use

K081427 510(k) Number (if known):

Device Name:

Browne OPA Test Strip

Indications for Use:

The Browne OPA Test Strip is a concentration monitor for use in ortho-phthalaldehydecontaining germicide solutions with a minimum effective concentration of 0.3%.

The Browne OPA Test Strip is dedicated for use with Cidex™ OPA solution

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

Over-The-Counter Use _ X (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)

Shila A. Murphy, MD

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

510(k) Number:

Page 1 of 1