OPACIDEN OPA REAGENT STRIPS

K070419 · Hach Company · JOJ · Aug 31, 2007 · General Hospital

Device Facts

• Record ID: K070419
• Device Name: OPACIDEN OPA REAGENT STRIPS
• Applicant: Hach Company
• Product Code: JOJ · General Hospital
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Opaciden OPA Solution Test Strips are a concentration monitor dedicated for use with Opaciden OPA Solution with a minimum recommended concentration of 0.3%.

Device Story

Opaciden OPA Solution Test Strips are white polystyrene strips (3.25 x 0.2 inch) featuring a yellow reagent indicator pad. Used by healthcare personnel to verify germicide concentration in Opaciden OPA solutions. Operation involves immersing the pad in the germicide sample for 2 seconds, removing, shaking off excess, and holding horizontally for 60 seconds. Chemical reaction between OPA and sodium sulfite in the pad increases pH, triggering a color change from yellow to magenta if OPA concentration exceeds the 0.3% MRC. The visual color change provides immediate feedback to the user regarding the efficacy of the disinfectant solution, ensuring it meets the required concentration for high-level disinfection.

Clinical Evidence

Bench testing only. Performance established by testing indicators in germicide solutions containing 0.3% and 0.4% ortho-phthalaldehyde. Results showed no false negatives at 0.4% and no false positives at 0.3%.

Technological Characteristics

White polystyrene strip with a 0.2 x 0.2 inch reagent pad. Sensing principle: chemical reaction between ortho-phthalaldehyde and sodium sulfite, causing a pH-dependent color change (yellow to magenta) via a pH indicator. Dedicated for use with Opaciden OPA germicide solution.

Indications for Use

Indicated for monitoring the concentration of ortho-phthalaldehyde (OPA) in Opaciden OPA germicide solutions to ensure a minimum recommended concentration (MRC) of 0.3% is maintained.

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

Submission Summary (Full Text)

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Opaciden OPA Solution Test Strips 510(k) Submission Hach Company

## 510(k) SUMMARY

K070419

| Prepared: | August |
|-----------|--------|
|-----------|--------|

gust 30, 2007

- Submitter: Hach Company
Address: 23575 County Road 106 Elkhart, IN 46514 U.S.A. [phone]

Contact: David A. Morris, Ph.D. Director of Research

AUG 3 I 2007

- Device Trade/ Opaciden® OPA Solution Test Strips Proprietary Name:
High Level Disinfectant (Indicator) Device Common Name:

- Classification Name: Chemical Indicator for Liquid Chemical Germicide. 21CFR 880.2800 (b) Class II (Physical/Chemical Sterilization Process Indicator). Product Code: JOJ.
- Browne Cidex™ OPA Indicator Predicate Device:
- Device Description: The Opaciden OPA Solution Test Strip is a white polystyrene strip. of dimension 3.25 by 0.2 inch, with a 0.2 by 0.2 inch square yellow indicator pad at one end. It is intended for use exclusively with Opaciden OPA Germicide solutions to determine the germicide concentrations. The reagent pad is immersed in the sample and removed after 2 seconds. Excess sample is shaken off the pad and the strip is kept horizontal for 60 seconds. The chemical reagents in the indicator pad causes the pad to change color from yellow to magenta in OPA solutions with an ortho-phthalaldehyde concentration greater than the MRC of 0.3% OPA.
- The Opaciden OPA Solution Test Strips are a concentration Intended Use: monitor dedicated for use with Opaciden OPA Solution with a minimum recommended concentration of 0.3%.

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Opaciden OPA Solution Test Strips

| Technological | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics: | ortho-Phthalaldehyde (OPA) reacts with sodium sulfite contained<br>in the indicator pad to form a sulfite addition product and an<br>equivalent amount of base. The increase in pH due to the reaction<br>with OPA causes a color change of the pH indicator present in the<br>pad. When the concentration of ortho-phthalaldehyde is greater<br>than the MRC of 0.3%, a color change from light yellow to<br>magenta occurs in the indicator pad of the OPA Opaciden Solution<br>Test Strip. The pad of the predicate contains a different pH<br>indicator that undergoes a different color change due to pH. The<br>pad of the predicate device changes from light blue to purple when<br>the OPA concentration is greater than 0.3%. |
| Assessment of | |
| Performance: | The performance characteristics of the Opaciden OPA Solution Test Strips<br>were established by testing indicators in germicide solutions containing<br>0.3% and 0.4% ortho-phthalaldehyde. No false negatives were observed<br>in solutions containing 0.4% ortho-phthalaldehyde. No false positives<br>were observed in solutions containing 0.3% ortho-phthalaldehyde. The<br>results of the testing indicate that the Opaciden OPA Solution Test Strips<br>are suitable for their intended use. |
| Conclusion: | The Opaciden OPA Solution Test Strips are intended for exclusive<br>use with Opaciden OPA germicide solution whereas the predicate<br>device is intended for use with Browne Cidex OPA solution. The<br>devices have the same intended use as concentration monitors for<br>ortho-phthalaldehyde germicide solutions with a minimum<br>recommended concentration of 0.3%. Both systems effectively<br>measure the concentration of OPA in the germicide solutions that<br>they are intended to monitor. The Opaciden OPA Solution Test<br>Strips have no technological characteristics that raise new types of<br>safety or effectiveness questions. |

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2007

Dr. David A. Morris, Ph.D. Director, Research and Technology HACH Company 23575 County Road 106 Elkhart, Illinois 46514

Re: K070419

Trade/Device Name: Opaciden OPA Solution Test Strips Regulation Number: 21 CFR 880.2800 (b) Regulation Name: Physical/Chemical Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 12, 2007 Received: August 16, 2007

Dear Dr. Morris:

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 - Dr. Morris

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 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 vours.

Ours

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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Opaciden® OPA Solution Test Strips Aug 12, 2007 - 510(k) Submission K070419 Hach Company

## Indications for Use

510(k) Number (if known): 510(k) Number: K070419

Opaciden OPA Solution Test Strips Device Name:

Indications for Use:

The Opaciden OPA Solution Test Strips are a concentration monitor dedicated for use in The Opaciden Of A Solition Tool Derpo de oblions with a minimum recommended ortho-pintlanadeliyate-containing genixo. A Solution Test Strips are dedicated for use with the Ciden Opaciden OPA Solution.

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sile A Murphy, K
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K70419