(211 days)
K100-0118, K100-0106
Not Found
No
The device is a simple chemical test strip that changes color based on the presence of ozone. There is no mention of any computational analysis, image processing, or learning algorithms.
No.
The device is an ozone test strip designed to indicate the presence of ozone in water used in hemodialysis, not to treat a medical condition or disease.
No
The device is designed to indicate the presence and concentration of ozone in water used in hemodialysis, not to diagnose a medical condition in a patient. It is a quality control tool for medical equipment, not a diagnostic device for human health.
No
The device description clearly states it is a "reagent test strip comprised of a pad impregnated with chemicals... attached to a plastic strip for handling," indicating it is a physical, hardware-based device.
Based on the provided information, the Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips are an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is designed to indicate the presence of ozone in water used in hemodialysis. This involves testing a sample (water) in vitro (outside of the body) to provide information relevant to a medical procedure (hemodialysis).
- Device Description: It's a reagent test strip that changes color upon contact with ozone in the water sample. This is a common format for IVD tests that analyze chemical components in a sample.
- Context of Use: The water being tested is used in hemodialysis, a medical treatment. Ensuring the quality of this water is crucial for patient safety during the procedure.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and nature of the device clearly align with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body or other sources for the purpose of providing information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. In this case, the "other source" is the water used in a medical treatment, and the information provided is critical for the safety and effectiveness of that treatment.
N/A
Intended Use / 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.
Product codes
MSY
Device Description
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with Ozone. The pad is attached to a plastic strip for handling.
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
The data confirms the product consistently generates color change which meets the color block for the reference solution concentration. These data demonstrate appropriate performance for use in hemodialysis water used in treatment.
Key Metrics
Not Found
Predicate Device(s)
Ultra Low Total Chlorine (K100-0118), E-Z Chek® Sensitive Total Chlorine (K100-0106)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5665 Water purification system for hemodialysis.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the letters "RPC" in a bold, sans-serif font. The letters are black and outlined in black, giving them a distinct appearance. The "RP" is enclosed in a square.
Page 1 of 2
K132344
Page 1 of 2
510(k) SUMMARY
| Prepared: | February 05, 2014 |
|---|---|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 1643 W. Modern Court |
| 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- |
-
|
| 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
(RPC) E-Z Chek® Ozone Test Strips
(K100-0111) are substantially equivalent to
the Ultra Low Total Chlorine (K100-0118)
and E-Z Chek® Sensitive Total Chlorine
(K100-0106) Test Strips |
| Device Description: | Device is semi-quantitative, reagent test
strip comprised of a pad impregnated with
chemicals, which change color upon
contact with Ozone. The pad is attached to
a plastic strip for handling. |
| Intended 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. |
| Technological Characteristics: | The E-Z Chek® Ozone Test Strips (K100-
- will detect ozone concentrations
equal to and above 0.0 ppm for Ozone in
water used to prepare dialysate. The test
strip pad contains a specialized chemical
reagent that reacts with Ozone in water.
The reaction results in a color change
which correlates to the concentration of |
| | ozone in the test water. |
| Performance: | The data confirms the product consistently
generates color change which meets the
color block for the reference solution
concentration. These data demonstrate
appropriate performance for use in
hemodialysis water used in treatment. |
| Conclusion: | The Reprocessing Products Corporation
(RPC) E-Z Chek® Ozone Test Strips
(K100-0111) have the same intended use as
the predicate device. Both the test strips
and the meters are designed to detect the
presence of ozone in water. The
Reprocessing Products Corporation (RPC)
E-Z Chek® Ozone Test Strips (K100- - has no characteristics which raise
new types of safety and effectiveness
questions. The Reprocessing Products
Corporation (RPC) E-Z Chek® Ozone Test
Strips (K100-0111) can be used to detect
the presence of ozone in water |
1
Image /page/1/Picture/1 description: The image shows the letters "RPC" in a bold, sans-serif font. The letters are black and stand out against a white background. To the left of the letters "RPC" is the letter "RP" inside of a box. The letters are also in a bold, sans-serif font.
Page 2 of 2
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
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.
3
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
4
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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