(224 days)
Not Found
No
The device description and intended use clearly describe a simple chemical indicator test strip, with no mention of AI or ML. The performance studies compare it to a predicate chemical indicator.
No
The device is a test strip designed to measure the concentration of ortho-phthalaldehyde in a solution, not to treat any medical condition or patient.
No
The device is a chemical indicator test strip used to determine the concentration of an active ingredient in a solution, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad...affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to determine the concentration of a chemical (ortho-phthalaldehyde) in a solution (RAPICIDE OPA-28 Solution). This solution is used for disinfecting medical devices, not for diagnosing a condition in a patient.
- Device Description: The device is a chemical indicator strip designed to react with a specific chemical in a solution. It does not interact with biological samples from a patient.
- Anatomical Site/Patient Age Range: These fields are marked as "Not Applicable," further indicating that the device is not used on or in a patient.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description. It's a quality control tool for a disinfectant solution.
N/A
Intended Use / Indications for Use
The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad that has been chemically treated to detect OPA. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the RAPICIDE OPA-28 Test Strips was evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies and compared to test results obtained with Serim DISINTEK OPA Test Strips evaluated in Cidex OPA solutions at the MEC and above as well. The performance of the RAPICIDE OPA-28 Test Strips is substantially equivalent to the predicate device, Serim DISINTEK OPA Test Strips.
Summary of Non-clinical Testing:
Shelf Life: Passed
Open Bottle Stability: Passed
Effect of Contaminants: Passed
Effect of Temperature Deviation: Passed
Effect of pH Deviation: Passed
Analytical Specificity: Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
SERIM Research Corporation 510(k) Premarket Notification RAPICIDE OPA-28 Test Strip
・
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:
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14120652
510(K) SUMMARY
OCT 12 2012
| Prepared: | February 27, 2012 |
|---|---|
| Submitter: | Serim Research Corporation |
| Address | P.O. Box 4002 |
| Elkhart IN 46514 | |
| Phone: | |
| Fax: | 574-264-3440 |
| 574-266-6222 | |
| Contact: | Patricia A. Rupchock |
| Director of Regulatory Affairs | |
| Device Trade Name: | RAPICIDE OPA-28 Test Strips |
| Common or Usual Name: | Indicator for ortho-phthalaldehyde (OPA) high level |
| disinfectant | |
| Device Classification Name: | Chemical Indicators for Liquid Chemical Germicide. (b) |
| Class II (Physical/Chemical Sterilization Process | |
| Indicator). | |
| Product Code: | JOJ |
| Class: | II |
| Regulation Number: | 21CFR 880.2800 |
| Substantial Equivalence: | The RAPICIDE OPA-28 Test Strip is substantially |
| equivalent to Serim® DISINTEK™ OPA Test Strips, Serim | |
| Research Corporation, P/N 5121; K081370. | |
| Device Description: | The device is a qualitative, single use, reagent test strip |
| made up of a 0.40 inch square indicator pad that has been | |
| chemically treated to detect OPA. The pad is affixed to one | |
| end of a 3.25 inch by 0.40 inch white opaque polystyrene | |
| strip. | |
| Intended Use: | The RAPICIDE OPA-28 Test Strip is a chemical indicator |
| for use in determining whether the concentration of ortho- | |
| phthalaldehyde, the active ingredient in RAPICIDE OPA- | |
| 28 Solution, is above or below the established Minimum | |
| Recommended Concentration (MRC) of 0.35%. |
1
Technological Characteristics:
The RAPICIDE OPA-28 Test Strip contains two reacting chemicals, a stabilizer, and other non-reacting ingredients. The reaction process involved with the test strip is based on a two step reaction. The first step involves a reaction in which a chemical reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA in excess reacts with a second chemical to form a colored compound, resulting in green color. The test pad size of 0.4" x 0.4" allows for easy interpretation of the change in color. The device will reliably indicate if the OPA concentration-is-above-or-below-the-MRC-of-0.35%-OPA .- -
- 时时彩
Performance:
The performance of the RAPICIDE OPA-28 Test Strips was evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies and compared to test results obtained with Serim® DISINTEKTM OPA Test Strips evaluated in Cidex OPA solutions at the MEC and above as well. The performance of the RAPICIDE OPA-28 Test Strips is substantially equivalent to the predicate device, Serim® DISINTEK™ OPA Test Strips.
Summary of Non-clinical Testing
The following table summarizes the non-clinical testing performed to demonstrate that the Rapicide OPA-28 Test strip is safe and effective in monitoring the OPA concentration in Rapicide OPA-28 Disinfectant Solution.
| Study | Result |
|---|---|
| Shelf Life | Passed |
| Open Bottle Stability | Passed |
| Effect of Contaminants | Passed |
| Effect of Temperature Deviation | Passed |
| Effect of pH Deviation | Passed |
| Analytical Specificity | Passed |
The RAPICIDE OPA-28 Test Strips have the same Conclusion: intended use as the predicate device. Both test strips measure the potency of ortho-phthalaldehyde (OPA) in disinfectant solution, to determine whether it is above or Recommended the Minimum or Effective below Concentration. The difference between the proposed OPA indicator and the predicate device is its use with a different OPA based disinfectant. We are adding a new indication for use to the predicate device, namely the use in the RAPICIDE OPA-28 solution. This difference does not raise any new safety or effectiveness issues.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 12 2012
Serim Research Corporation Ms. Patricia Rupchock Director of Regulatory Affairs 3506 Reedy Drive Elkhart, Indiana 46514
Re: K120652
Trade/Device Name: Rapicide OPA-28 Test Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: October 2, 2012 Received: October 4, 2012
Dear Ms. Rupchock:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Rupchock
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
K12 0652
CONFIDENTIAL
SERIM Research Corporation 510(k) Premarket Notification RAPICIDE OPA-28 Test Strip
INDICATIONS FOR USE
510(k) Number (if known): K
RAPICIDE OPA-28 Test Strips Device Name:
Indications For Use: The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the ... the ... concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.
Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (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)
Elizabeth F. Clamton Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
な