OPACIDEN OPA REAGENT STRIPS by HACH COMPANY

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Opaciden OPA Solution Test Strips, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No false negatives in solutions with 0.4% OPA.	No false negatives observed in solutions containing 0.4% ortho-phthalaldehyde.
No false positives in solutions with 0.3% OPA.	No false positives observed in solutions containing 0.3% ortho-phthalaldehyde.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state a specific numerical sample size for the test set. It mentions "testing indicators in germicide solutions containing 0.3% and 0.4% ortho-phthalaldehyde." This implies a set of test strips were used in these two concentration levels. The exact number of test strips used at each concentration is not provided.
Data Provenance: The data appears to be from a prospective study conducted by the Hach Company for their 510(k) submission. The country of origin is implicitly the U.S.A., given the submitter's address and the FDA submission process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts or adjudicators to establish ground truth for this device. The ground truth (OPA concentration) was established by preparing germicide solutions at known concentrations (0.3% and 0.4%).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is described. The assessment appears to be based on whether the test strip exhibited the expected color change (yellow to magenta) at the specified OPA concentrations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study typically involves human readers assessing cases. The Opaciden OPA Solution Test Strip is an indicator device; its performance is based on a chemical color change, not human interpretation of complex images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance assessment described is inherently a standalone test of the device. The "algorithm" is the chemical reaction and color change of the test strip itself. No human interpretation is involved beyond visually observing the color change.

7. Type of Ground Truth Used

The ground truth used was known solution concentrations. Germicide solutions were prepared with exact concentrations of ortho-phthalaldehyde (0.3% and 0.4%).

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a chemical indicator device, not an AI or algorithm-based system that requires training data.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, there is no training set described for this device.

Summary

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

510(k) SUMMARY

K070419

Prepared:	August
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gust 30, 2007

Submitter: Hach Company
Address: 23575 County Road 106 Elkhart, IN 46514 U.S.A. (219) 262-2060

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 containedin the indicator pad to form a sulfite addition product and anequivalent amount of base. The increase in pH due to the reactionwith OPA causes a color change of the pH indicator present in thepad. When the concentration of ortho-phthalaldehyde is greaterthan the MRC of 0.3%, a color change from light yellow tomagenta occurs in the indicator pad of the OPA Opaciden SolutionTest Strip. The pad of the predicate contains a different pHindicator that undergoes a different color change due to pH. Thepad of the predicate device changes from light blue to purple whenthe OPA concentration is greater than 0.3%.
Assessment of
Performance:	The performance characteristics of the Opaciden OPA Solution Test Stripswere established by testing indicators in germicide solutions containing0.3% and 0.4% ortho-phthalaldehyde. No false negatives were observedin solutions containing 0.4% ortho-phthalaldehyde. No false positiveswere observed in solutions containing 0.3% ortho-phthalaldehyde. Theresults of the testing indicate that the Opaciden OPA Solution Test Stripsare suitable for their intended use.
Conclusion:	The Opaciden OPA Solution Test Strips are intended for exclusiveuse with Opaciden OPA germicide solution whereas the predicatedevice is intended for use with Browne Cidex OPA solution. Thedevices have the same intended use as concentration monitors forortho-phthalaldehyde germicide solutions with a minimumrecommended concentration of 0.3%. Both systems effectivelymeasure the concentration of OPA in the germicide solutions thatthey are intended to monitor. The Opaciden OPA Solution TestStrips have no technological characteristics that raise new types ofsafety 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).