(88 days)
K910320A
Not Found
No
The device description details a chemical reaction on a test strip that changes color based on hydrogen peroxide concentration. There is no mention of computational analysis, algorithms, or learning processes.
No
The device is a test strip designed to indicate the concentration of hydrogen peroxide in a sterilizing solution, not to treat or diagnose a medical condition in a patient.
No
The device is used to test the concentration of hydrogen peroxide in a sterilizing and disinfecting solution, not to diagnose a medical condition in a patient.
No
The device description clearly outlines a physical test strip with a reagent pad and polystyrene handle, which are hardware components. The mechanism of action involves a chemical reaction on the pad, not software processing.
Based on the provided information, the SPOROX® Test Strips are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to indicate the concentration of hydrogen peroxide in a disinfecting and sterilizing solution (SPOROX™ Solution). This solution is used to disinfect or sterilize medical devices or other items, not to diagnose or monitor a condition in a human body.
- Sample Type: The test is performed on the SPOROX™ Solution itself, which is an external chemical solution, not a biological sample from a human.
- Device Description: The description details a chemical reaction on a test strip to detect the presence and concentration of hydrogen peroxide in the solution. This is a chemical test of a non-biological substance.
- Anatomical Site and Patient Information: The document explicitly states "Not Applicable" for Anatomical Site and "Not Applicable" for Indicated Patient Age Range, further indicating it's not used on or for a patient.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. They typically involve testing biological samples (like blood, urine, tissue) from a human.
The SPOROX® Test Strips are a quality control tool for a chemical disinfectant solution, not a diagnostic tool for a human.
N/A
Intended Use / Indications for Use
SPOROX® Test Strips provide a rapid, convenient, semiquantitative means of indicating whether effective concentrations of hydrogen peroxide are present in SPOROX™ Sterilizing and Disinfecting Solution. The SPOROX® Test Strips indicate concentrations of hydrogen peroxide but do not confirm disinfection or sterilization.
Product codes
JOJ
Device Description
The SPOROX™ Test Strips consist of a 0.2 x 0.2 inch reagentcontaining pad attached to one end of a 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed in the sample for five seconds. The strip is rotated to a vertical position with the pad up to allow excess sample to drain by gravity and then is covered with a chamber to prevent sample evaporation. The reagent pad is observed 15 minutes after immersion. If the pad is completely brown/black, the SPOROX™ Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0% (the minimum effective concentration or MEC). If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad.
The reagent pad contains iodide and starch plus a reducing compound that prevents visible reaction when the hydrogen peroxide concentration is at or below the MEC. When the peroxide level is in sufficient excess of the MEC, the surplus oxidizes the iodide to iodine which in turn forms a dark-colored complex with the starch.
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
SPOROX™ Test Strips from three trial production lots were used by seven participants in blind studies to test SPOROX™ standards assayed by a titrimetric procedure. At 6.05% hydrogen peroxide, 0 out of 168 results were PASS, giving a test specificity (lack of false PASS results) of 1.00. At hydrogen peroxide concentrations of 6.58% and 7.00% respectively, 41 out of 84 and 165 out of 168 results were PASS. These results show that the SPOROX® Test Strips effectively indicate when the hydrogen peroxide concentration in SPOROX™ Disinfecting and Sterilizing Solution is at or below its MEC of 6.0%.
Key Metrics
Specificity: 1.00 (at 6.05% hydrogen peroxide)
Predicate Device(s)
K910320A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows a logo for "Serim RESEARCH CORP". The word "Serim" is in a large, bold, sans-serif font, with the "i" replaced by a stylized image that resembles a flame or a drop. Above the right side of "Serim" is the trademark symbol "TM". Below "Serim" in a smaller, sans-serif font is the text "RESEARCH CORP".
P.O. Box 4002, Elkhart, IN 46514-0002 • (219) 264-3440 • FAX (219) 266-6222
AUG 2 9 1997
510(k) SUMMARY
SPOROX® Test Strips
SUBMITTED BY:
James E. Christner Serim Research Corporation P.O. Box 4002 Elkhart, IN 46514
(219) 264-3440 Phone : (219) 266-6222 Fax :
James E. Christner Contact Person:
May 29, 1997 Date Prepared:
James E. Christner
May 29, 1997
DEVICE NAME:
SPOROX™ Test Strips Trade Name: Test Strips for Hydrogen Peroxide in SPOROX™ Common Name: Sterilizing and Disinfecting Solution Classification Chemical Sterilization Process Indicator Name :
LEGALLY MARKETED EQUIVALENT DEVICE
This product is similar in design, composition, and function to the Peracetic Acid Reagent Strips manufactured by Serim Research Corporation which was the subject of Premarket Notification The product is similar in utility to a titrimetric #K910320A. Supportive data for substantial equivalence to the assay. latter was obtained.
DESCRIPTION OF THE SPOROX™ TEST STRIP:
The SPOROX™ Test Strips consist of a 0.2 x 0.2 inch reagentcontaining pad attached to one end of a 0.2 x 3.25 inch The reagent pad is immersed in the sample polystyrene handle. The strip is rotated to a vertical position for five seconds. with the pad up to allow excess sample to drain by gravity and then is covered with a chamber to prevent sample evaporation. The reagent pad is observed 15 minutes after immersion. If the pad is completely brown/black, the SPOROX™ Sterilizing and
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Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0% (the minimum effective concentration or MEC). If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad.
The reagent pad contains iodide and starch plus a reducing compound that prevents visible reaction when the hydrogen peroxide concentration is at or below the MEC. When the peroxide level is in sufficient excess of the MEC, the surplus oxidizes the iodide to iodine which in turn forms a dark-colored complex with the starch.
INTENDED USE:
SPOROX® Test Strips provide a rapid, convenient, semiquantitative means of indicating whether effective concentrations of hydrogen peroxide are present in SPOROX™ Sterilizing and Disinfecting Solution. The SPOROX® Test Strips indicate concentrations of hydrogen peroxide but do not confirm disinfection or sterilization.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:
SPOROX® Test Strips are used for determining hydrogen peroxide levels in SPOROX® Disinfecting and Sterilizing Solution whereas the Serim Peracetic Acid Reagent Strips are used for determining peracetic acid levels in disinfectants employed in hemodialyzer Both tests consist of dry reagent-containing reprocessing. paper pads attached to plastic handles. Both contain a reducing compound which prevents visible reaction at ineffective concentrations of active ingredient and a starch/iodide Both give PASS/FAIL results. Completely colored indicator. reagent pads indicate effective levels of germicide. When the disinfectant solutions are at or below their MEC values, white areas are visible on the reagent pads.
STATEMENT OF SUBSTANTIAL EQUIVALENCE:
SPOROX™ Test Strips from three trial production lots were used by seven participants in blind studies to test SPOROX™ standards assayed by a titrimetric procedure. At 6.05% hydrogen peroxide, 0 out of 168 results were PASS, giving a test specificity (lack of false PASS results) of 1.00. At hydrogen peroxide concentrations of 6.58% and 7.00% respectively, 41 out of 84 and 165 out of 168 results were PASS. These results show that the SPOROX® Test Strips effectively indicate when the hydrogen peroxide concentration in SPOROX™ Disinfecting and Sterilizing Solution is at or below its MEC of 6.0%.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert C. Boguslaski, Ph.D. President Serim Research Corporation P.O. Box 4002 46514-0002 Elkhart, Indiana
AUG 29 1997
K972035 Re : Sporox Test Strips Trade Name: Regulatory Class: II Product Code: JOJ Dated: May 29, 1997 Received: June 2, 1997
Dear Dr. Boguslaski:
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, Drug, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Dr. Boguslaski
this response to your premarket notification submission does chis response or light have under sections 531 not arrect any obligation for devices under the Electronic Chrough J42 Or the net rol sovisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 marketed predicate with your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timoth y A. ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_
SPOROX™ Test Strips Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
(Per 21 CFR 801.109)
SPOROX® Test Strips provide a rapid, convenient semi-quantitative means of indicating whether effective concentrations of hydrogen means of Indicating whocher ore Sterilizing and Disinfecting e present in bst Strips indicate concentrations of Solution. Sofulion. The Brokon 1155 Confirm disinfection or sterilization.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ర్
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number | K972035 |
| Prescription Use | OR |
| Over-The-Counter Use X |
(Optional Format 1-2-96)
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