(89 days)
Not Found
No
The device description and intended use describe a chemical test strip that changes color based on the presence of chlorine. There is no mention of AI or ML in the provided text.
No
This device is a test strip for measuring residual chlorine in water used for equipment disinfection, not for treating any medical condition or affecting human body structure or function.
No
Explanation: The device is used to measure residual chlorine in water used for rinsing equipment, not to diagnose medical conditions in patients.
No
The device is a physical test strip with a chemically impregnated pad, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure residual chlorine in water used for rinsing equipment after disinfection. This is an environmental or industrial application, not a diagnostic test performed on a biological sample from a human body to diagnose a disease or condition.
- Device Description: The device measures a chemical (chlorine) in water, not a biological marker in a human sample.
- Anatomical Site: Not applicable, as it's not used on a human body.
- Input Imaging Modality: Not applicable, as it's a chemical test strip.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
E-Z Chek® Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5pm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between 0ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).
Product codes (comma separated list FDA assigned to the subject device)
MSY
Device Description
Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) is semi-quantitative or qualitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with free chlorine and combined chlorine (monochloramines). 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The test data confirms the subject device and the predicate device consistently generates color change which meets the color block(s) for the reference solution concentrations tested. This data demonstrates appropriate performance for the detection of residual free chlorine in rinse water that was used in disinfection of hemodialysis equipment fluid pathways.
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.
Serim Residual Chlorine Test Kit, 510(k) K901734.
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
§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2022
Reprocessing Products Corporation (RPC) Dave Cox Director of Quality Assurance and Regulatory Affairs 1643 W. Modern Court Tucson, Arizona 85705
Re: K222167
Trade/Device Name: E-Z Chek Chlorine Residual Test Strips (K100-0101B) Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: II Product Code: MSY Dated: July 19, 2022 Received: July 21, 2022
Dear Dave Cox:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222167
Device Name
E-Z Chek® Residual Chlorine Test Strips, K100-0101B.
Indications for Use (Describe)
E-Z Chek® Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5pm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between 0ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for RPC. The logo consists of the letters "RP" inside of a red square with a red arrow pointing upwards. To the right of the square are the letters "RPC" in black.
510(k) SUMMARY 21 CFR 807.92
| Prepared: | July 19, 2022 |
|---|---|
| Submitter/Owner: | Reprocessing Products Corporation (RPC) |
| Establishment Registration | |
| Number: | 2028411 |
| Address: | 1643 W. Modern Court |
| Tucson, AZ 85705 | |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Dave Cox |
| Device Trade Name: | E-Z Chek® Residual Chlorine Test Strips (K100- |
| 0101B) | |
| Device Common or Usual Name: | Residual Chlorine Test Strips |
| Device Classification Name: | Strip, Test, Reagent, Residuals for Dialysate, |
| Disinfectant | |
| Product Code: | MSY |
| Class: | II |
| Regulation Number: | 876.5665 |
| Predicate Device/Substantial | |
| Equivalence: | Serim Residual Chlorine Test Kit, |
| 510(k) K901734. | |
| Subject Device Description: | Reprocessing Products Corporation (RPC) E-Z |
| Chek® Residual Chlorine Test Strips (K100- | |
| 0101B) is semi-quantitative or qualitative, | |
| reagent test strip comprised of a pad | |
| impregnated with chemicals, which change color | |
| upon contact with free chlorine and combined | |
| chlorine (monochloramines). The pad is attached | |
| to a plastic strip for handling. | |
| Subject Device Indication for Use: | Reprocessing Products Corporation (RPC) |
| E-Z Chek® Residual Chlorine Test Strips (K100- | |
| 0101B) provide accurate and convenient means of | |
| measuring the concentration of free chlorine | |
| remaining in water when rinsing out equipment | |
| following disinfection. A rapid screening | |
| qualitative method will detect levels above 0.5ppm | |
| (mg/L) while the 30 second semi-quantitative | |
| method allows interpolation of concentration | |
| between 0ppm and 5ppm. The qualitative method | |
| can be used to determine that chlorine has been | |
| adequately rinsed from the equipment. The semi- | |
| quantitative method may be useful when corrective | |
| measures are undertaken on equipment retaining | |
| higher levels of chlorine for extended periods and | |
| for testing any containers disinfected with free | |
| chlorine (bleach). | |
| Technological Characteristics | |
| Summary: | E-Z Chek® Residual Chlorine Test Strips (K100- |
| 0101B) and Serim Residual Chlorine Test Kit both | |
| react with free chlorine and monochloramines. The | |
| reagent pad on the strip is buffered to pH 6.8 and | |
| contains potassium iodide. Free chlorine oxidizes | |
| the colorless indicator compound to form a | |
| pink/purple oxidation reaction. Monochloramine | |
| oxidizes the potassium iodide to iodine, which in | |
| turn oxidizes the indicator to the colored form. | |
| Non-clinical Performance Data: | The test data confirms the subject device and the |
| predicate device consistently generates color | |
| change which meets the color block(s) for the | |
| reference solution concentrations tested. This data | |
| demonstrates appropriate performance for the | |
| detection of residual free chlorine in rinse water | |
| that was used in disinfection of hemodialysis | |
| equipment fluid pathways. | |
| Conclusion: | Reprocessing Products Corporation (RPC) E-Z |
| Chek® Residual Chlorine Test Strips (K100-0101B) | |
| have the same intended use as the predicate device. | |
| Both test strips are designed to detect the presence | |
| of free chlorine in water. Reprocessing Products | |
| Corporation (RPC) E-Z Chek® Residual Chlorine | |
| Test Strips (K100-0101B) are as safe, effective, and | |
| performs as well as the predicate device. The | |
| subject device has no characteristics which raise | |
| new types of safety or effectiveness compared to | |
| the predicate device. |
4
Image /page/4/Picture/0 description: The image shows the logo for RPC. The letters "RP" are inside of a red square with a red arrow pointing up. The letters "RPC" are in bold black font and are next to the red square.
5
Image /page/5/Picture/0 description: The image shows the logo for RPC. The letters "RP" are in a red box with a white border. To the right of the box are the letters "RPC" in black.