E-Z CHECK OZONE TEST STRIPS
Device Facts
| Record ID | K132344 |
|---|---|
| Device Name | E-Z CHECK OZONE TEST STRIPS |
| Applicant | Reprocessing Products Corporation (Rpc) |
| Product Code | MSY · Gastroenterology, Urology |
| Decision Date | Feb 25, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
Indications for Use
The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
Device Story
Semi-quantitative reagent test strip; consists of chemical-impregnated pad on plastic handle. Used to detect ozone in hemodialysis water. User dips strip into water sample; chemical reagent reacts with ozone, causing color change. User compares color change to reference chart to determine ozone concentration (0.0 to >0.5 mg/L). Provides rapid, visual assessment of water quality for hemodialysis preparation. Helps ensure water safety by confirming absence or specific levels of ozone.
Clinical Evidence
Bench testing only. Data confirms product consistently generates color changes corresponding to reference solution concentrations, demonstrating appropriate performance for hemodialysis water monitoring.
Technological Characteristics
Semi-quantitative reagent test strip; plastic handle with chemical-impregnated pad. Colorimetric detection principle. No energy source required. Manual operation.
Indications for Use
Indicated for the detection of ozone in water used for hemodialysis applications.
Regulatory Classification
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Special Controls
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Predicate Devices
- Ultra Low Total Chlorine (K100-0118)
- E-Z Chek® Sensitive Total Chlorine (K100-0106)
Submission Summary (Full Text)
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K132344
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# 510(k) SUMMARY
| Prepared: | February 05, 2014 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 1643 W. Modern Court<br>Tucson, AZ 85705 |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | E-Z Chek® Ozone Test Strips (K100-<br>0111) |
| Common or Usual Name: | Ozone Test Strips |
| Device Classification Name: | Strip, Hemodialysis Water, Ozone detector |
| Product Code: | MSY |
| Class: | II |
| Regulation Number: | 875.5665, 876.5820 |
| Substantial Equivalence: | The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Ozone Test Strips<br>(K100-0111) are substantially equivalent to<br>the Ultra Low Total Chlorine (K100-0118)<br>and E-Z Chek® Sensitive Total Chlorine<br>(K100-0106) Test Strips |
| Device Description: | Device is semi-quantitative, reagent test<br>strip comprised of a pad impregnated with<br>chemicals, which change color upon<br>contact with Ozone. The pad is attached to<br>a plastic strip for handling. |
| Intended Use: | The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Ozone Test Strips<br>(K100-0111) are designed to indicate the<br>presence of ozone in water used in<br>hemodialysis. The test strips will measure<br>equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and<br>>0.5 mg/L. |
| Technological Characteristics: | The E-Z Chek® Ozone Test Strips (K100-<br>0111) will detect ozone concentrations<br>equal to and above 0.0 ppm for Ozone in<br>water used to prepare dialysate. The test<br>strip pad contains a specialized chemical<br>reagent that reacts with Ozone in water.<br>The reaction results in a color change<br>which correlates to the concentration of |
| | ozone in the test water. |
| Performance: | The data confirms the product consistently<br>generates color change which meets the<br>color block for the reference solution<br>concentration. These data demonstrate<br>appropriate performance for use in<br>hemodialysis water used in treatment. |
| Conclusion: | The Reprocessing Products Corporation<br>(RPC) E-Z Chek® Ozone Test Strips<br>(K100-0111) have the same intended use as<br>the predicate device. Both the test strips<br>and the meters are designed to detect the<br>presence of ozone in water. The<br>Reprocessing Products Corporation (RPC)<br>E-Z Chek® Ozone Test Strips (K100-<br>0111) has no characteristics which raise<br>new types of safety and effectiveness<br>questions. The Reprocessing Products<br>Corporation (RPC) E-Z Chek® Ozone Test<br>Strips (K100-0111) can be used to detect<br>the presence of ozone in water |
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
Reprocessing Products Corporation Ted Williams Director of Quality and Regulatory Affairs 1643 W. Modern Court Tucson, AZ 85705
K132344 Re:
> Trade/Device Name: E-Z Chek® Ozone Test Strips (K100-011) Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: MSY Dated: February 5, 2014 Received: February 7, 2014
Dear Ted Williams,
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. Iisting 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.
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.
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Page 2 - Ted Williams
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 (OS) 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin Asher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K132344
#### Device Name
E-Z Chek® Ozone Test Strips (K100-0111)
## Indications for Use (Describe)
The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
ード FOR FOR FOR FOR FOA USE ONLY - 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 14 - 3 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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