(133 days)
No
The device is a simple chemical indicator test strip that relies on a color change reaction, not computational analysis.
No
The device is a test strip designed to measure the concentration of an active ingredient (OPA) in a disinfectant solution, not for therapeutic use on a patient.
No
Explanation: The device is used to test the concentration of a chemical solution (CIDEX® OPA Solution), not to diagnose a medical condition in a patient. It determines if the solution's active ingredient is above or below a minimum effective concentration.
No
The device description clearly outlines a physical test strip with a reagent-containing pad and a polystyrene handle, which are hardware components. The process involves immersing the strip in a solution and comparing the resulting color to a standard, which is a manual, non-software-based method.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the test strips are used to determine the concentration of an active ingredient (OPA) in a solution (CIDEX* OPA Solution). This is a diagnostic test performed in vitro (outside of the body) on a sample (the CIDEX* OPA Solution).
- Device Description: The description details a chemical indicator that reacts with a sample to produce a result (color change) that is interpreted to determine a characteristic of the sample (OPA concentration). This aligns with the nature of an IVD.
- Performance Studies: The performance studies describe testing the device's ability to accurately indicate the OPA concentration in standard solutions. This is typical testing for an IVD to demonstrate its analytical performance.
- Predicate Device: The mention of a predicate device (K915170; Cidex® Solution Test Strips) further supports its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
While the device is used to assess the effectiveness of a disinfectant solution, the test itself is performed on the solution to determine its chemical composition, not on a patient or biological sample. This is a key characteristic of an IVD used for quality control or monitoring of a process or product.
N/A
Intended Use / Indications for 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.
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 effective concentration of 0.3% OPA. CIDEX® OPA Solution Test Strips cannot be used to validate the sterilization or disinfection process.
Product codes
JOJ
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The study involved blind testing of CIDEX® OPA Solution Test Strips by eight individuals (including three inexperienced in laboratory techniques) using three trial production lots and CIDEX® OPA Solution standards. A total of 324 results were obtained for 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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
specificity (lack of false PASS results) of 1.00
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 • (219) 264-3440 • FAX (219) 266-6222
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: | (219) 264-3440 |
|---|---|
| Fax: | (219) 266-6222 |
| E-mail: | jchristner@serim.com |
| 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 |
| 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.
1
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%.
2
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
3
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 (301) 594-4692. Additionally, for questions on Compriance at (501) sectising of your device, please contact che promocion and adversional (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
Page_1_Pf
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
P.2