(89 days)
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).
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.
The Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) are designed to provide an accurate and convenient method for measuring the concentration of free chlorine remaining in water after rinsing equipment following disinfection.
Here's an analysis of the acceptance criteria and the study conducted for the device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating that the subject device consistently generates color change that meets the color blocks for reference solution concentrations, similar to the predicate device. The performance is assessed qualitatively (for detecting levels above 0.5 ppm) and semi-quantitatively (for interpolating concentrations between 0 ppm and 5 ppm).
From the "Non-clinical Performance Data" section:
"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."
Given this, the table would look like this:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Consistently generate color change that meets reference color blocks for tested solution concentrations. | Achieved: The test data confirms the E-Z Chek® Residual Chlorine Test Strips consistently generate color change which meets the color blocks for the reference solution concentrations tested. |
| Appropriately perform for the detection of residual free chlorine in rinse water used in hemodialysis equipment disinfection. | Achieved: The data demonstrates appropriate performance for the detection of residual free chlorine in rinse water that was used in disinfection of hemodialysis equipment fluid pathways, indicating it functions as intended for both qualitative (detecting > 0.5 ppm) and semi-quantitative (interpolating 0-5 ppm) methods. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "reference solution concentrations tested" implicitly indicating multiple concentrations were used. The data provenance is not specified (e.g., country of origin, retrospective/prospective), but it is a non-clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by using "reference solution concentrations," which implies a controlled laboratory setting where the actual chlorine concentrations are known.
4. Adjudication Method for the Test Set:
No adjudication method is described. The comparison is against "color block(s) for the reference solution concentrations tested," suggesting a direct visual comparison by the test personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study is a non-clinical performance evaluation comparing the subject device's color change against known reference solutions and its predicate device. This device is a test strip, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This device is a manual test strip that requires human observation and interpretation of color change to determine chlorine levels. It does not involve an algorithm.
7. The Type of Ground Truth Used:
The ground truth used is based on known, controlled reference solution concentrations of free chlorine in water. These are prepared solutions with precisely measured amounts of chlorine.
8. The Sample Size for the Training Set:
This device is a chemical test strip, not a machine learning or AI-driven product. Therefore, there is no "training set" in the context of algorithm development. The performance data is generated through testing the strips against various known concentrations.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this chemical test strip, this question is not applicable. The device's performance is inherently based on its chemical reactivity and the visual interpretation of the resulting color change against a predefined color chart.
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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
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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
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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) |
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510(k) SUMMARY 21 CFR 807.92
| Prepared: | July 19, 2022 |
|---|---|
| Submitter/Owner: | Reprocessing Products Corporation (RPC) |
| Establishment RegistrationNumber: | 2028411 |
| Address: | 1643 W. Modern CourtTucson, 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/SubstantialEquivalence: | Serim Residual Chlorine Test Kit,510(k) K901734. |
| Subject Device Description: | Reprocessing Products Corporation (RPC) E-ZChek® Residual Chlorine Test Strips (K100-0101B) is semi-quantitative or qualitative,reagent test strip comprised of a padimpregnated with chemicals, which change colorupon contact with free chlorine and combinedchlorine (monochloramines). The pad is attachedto 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 ofmeasuring the concentration of free chlorineremaining in water when rinsing out equipmentfollowing disinfection. A rapid screeningqualitative method will detect levels above 0.5ppm(mg/L) while the 30 second semi-quantitativemethod allows interpolation of concentrationbetween 0ppm and 5ppm. The qualitative methodcan be used to determine that chlorine has beenadequately rinsed from the equipment. The semi-quantitative method may be useful when correctivemeasures are undertaken on equipment retaininghigher levels of chlorine for extended periods andfor testing any containers disinfected with freechlorine (bleach). |
| Technological CharacteristicsSummary: | E-Z Chek® Residual Chlorine Test Strips (K100-0101B) and Serim Residual Chlorine Test Kit bothreact with free chlorine and monochloramines. Thereagent pad on the strip is buffered to pH 6.8 andcontains potassium iodide. Free chlorine oxidizesthe colorless indicator compound to form apink/purple oxidation reaction. Monochloramineoxidizes the potassium iodide to iodine, which inturn oxidizes the indicator to the colored form. |
| Non-clinical Performance Data: | The test data confirms the subject device and thepredicate device consistently generates colorchange which meets the color block(s) for thereference solution concentrations tested. This datademonstrates appropriate performance for thedetection of residual free chlorine in rinse waterthat was used in disinfection of hemodialysisequipment fluid pathways. |
| Conclusion: | Reprocessing Products Corporation (RPC) E-ZChek® Residual Chlorine Test Strips (K100-0101B)have the same intended use as the predicate device.Both test strips are designed to detect the presenceof free chlorine in water. Reprocessing ProductsCorporation (RPC) E-Z Chek® Residual ChlorineTest Strips (K100-0101B) are as safe, effective, andperforms as well as the predicate device. Thesubject device has no characteristics which raisenew types of safety or effectiveness compared tothe predicate device. |
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§ 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.