(87 days)
K100-0118, K100-0106
K100-0118, K100-0106
No
The device description and performance summary indicate a simple chemical reaction test strip with visual interpretation using color charts, with no mention of AI or ML.
No.
The device is a test strip for detecting chlorine in water used for dialysate preparation and dialysis equipment disinfection, not a device used for treating a disease or condition.
No
The device is designed to detect Free Chlorine and Total Chlorine in water, specifically for water used in dialysis equipment and dialysate preparation. It does not diagnose any medical condition in a patient.
No
The device is a physical test strip with a chemical pad and plastic strip, which are hardware components. The color charts are also physical components used for interpretation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to detect Free Chlorine and Total Chlorine in water. This water is used for preparing dialysate and for testing rinse water following dialysis equipment disinfection. This is an environmental or process control test, not a test performed on a human biological specimen.
- Device Description: The device tests water samples, not human samples like blood, urine, or tissue.
- Anatomical Site and Patient Age Range: These are listed as "Not Applicable," further indicating it's not used on a patient.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not meet that definition.
N/A
Intended Use / Indications for Use
The RPC Total Chlorine Test Strips are indicated for use in the monitoring of chlorine in water used to prepare dialysate and water used to rinse dialysis equipment.
The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
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 Free Chlorine or Chloramines. The pad is attached to a plastic strip for handling.
The color change is interpreted by the use of color blocks on two separate (ranges) color charts. Gradations for the Ultra-Low Total Chlorine (K100-0118) color chart include 0 ppm, 0.01 ppm, 0.02 ppm, 0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm. Gradations for the E-Z Chek® Sensitive Total Chlorine (K100-0106) color chart include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0 ppm.
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 confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine. These data demonstrate accurate detection performance, below, equal to, and above the dialysis level of 0.5 ppm for Free Chlorine and below, equal to, and above the dialysis level of 0.1 ppm for Chloramines (measured as Total Chlorine). These data demonstrate appropriate performance for use in testing dialysis equipment rinse water and for testing water for dialysate preparation.
Key Metrics
Not Found
Predicate Device(s)
The RPC Total Chlorine Test Strips are substantially equivalent to the SERIM® HISENSE ULTRA 0.1TM
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 "RP" inside of a square, followed by the letters "RPC" to the right of the square. The letters are all in black and are bolded. The letters are all capitalized and are in a sans-serif font.
Traditional 510k Premarket Notification Total Chlorine Test Strips
Page 1 of 2
MAY - 8 2009
510(k) SUMMARY
| Prepared: | February 6, 2009 |
|---|---|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 3655 N. Oracle Road |
| Tucson, AZ 85705 | |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | Two ranges: |
| Ultra Low Total Chlorine (K100-0118) and | |
| E-Z Chek® Sensitive Total Chlorine | |
| (K100-0106) Test Strips | |
| Common or Usual Name: | Total Chlorine Test Strips |
| Device Classification Name: | Strip, Test, Reagent, Residuals for |
| Dialysate, Disinfectant | |
| Product Code: | MSY |
| Class: | II |
| Regulation Number: | 875.5665 |
| Substantial Equivalence: | The RPC Total Chlorine Test Strips are |
| substantially equivalent to the SERIM® | |
| HISENSE ULTRA 0.1TM | |
| Device Description: | Device is semi-quantitative, reagent test |
| strip comprised of a pad impregnated with | |
| chemicals which change color upon contact | |
| with Free Chlorine or Chloramines. The | |
| pad is attached to a plastic strip for | |
| handling. | |
| Intended Use: | The RPC Total Chlorine Test Strips are |
| indicated for use in the monitoring of | |
| chlorine in water used to prepare dialysate | |
| and water used to rinse dialysis equipment. | |
| Technological Characteristics: | The Test Strips will detect chlorine |
| concentrations equal to, above and below | |
| 0.1 ppm for Total Chlorine in water used to | |
| prepare dialysate and 0.5 ppm for Free | |
| Chlorine in dialysis equipment rinse water. | |
| The test strip pad contains a specialized | |
| chemical reagent that reacts with Free | |
| Chlorine and Chloramines in water. The | |
| reaction results in a color change which is | |
| correlatable to the concentration of chlorine | |
| in the test water |
This document contains information considered CONFIDENTIAL to Reprocessing Products Corporation
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Image /page/1/Picture/0 description: The image contains a logo with the letters 'RP' inside a square, next to the letters 'RPC' in a larger font. There is an arrow pointing upwards above the letter 'P' in the square. The letters are all in black and the background is white.
.
: :
.
Traditional 510k Premarket Notification Total Chlorine Test Strips
.
.
| 090338 | 262 |
|---|---|
| cation | |
| Strips |
. .
| Page 2 of 2 | The color change is interpreted by the use
of color blocks on two separate (ranges)
color charts. Gradations for the Ultra-Low
Total Chlorine (K100-0118) color chart
include 0 ppm, 0.01 ppm, 0.02 ppm,
0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm.
Gradations for the E-Z Chek® Sensitive
Total Chlorine (K100-0106) color chart
include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0
ppm. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance: | The data confirm the product consistently
generates color change which correlates
with the color block for the Reference
solution concentration. Reference
solutions were used to evaluate
performance between 0 and 10 ppm
Chlorine. These data demonstrate accurate
detection performance, below, equal to, and
above the dialysis level of 0.5 ppm for Free
Chlorine and below, equal to, and above
the dialysis level of 0.1 ppm for
Chloramines (measured as Total Chlorine).
These data demonstrate appropriate
performance for use in testing dialysis
equipment rinse water and for testing water
for dialysate preparation. |
| Conclusion: | The RPC Total Chlorine Test Strips have
the same intended use as the predicate
device. Both test strips measure total
chlorine (free chlorine/chloramines) levels
in water. The RPC Total Chlorine Test
Strips have no characteristics which raise
new types of safety and effectiveness
questions. The RPC Total Chlorine Test
Strips can be used to monitor the level of
total chlorine (free chlorine/chloramines)
present in water used for preparation of
dialysate. The test strips can also be used to
detect residual chlorine levels in rinse
water from dialysis equipment after
disinfection. |
This document contains information considered CONFIDENTIAL to Reprocessing Products Corporation
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three wavy lines that resemble a caduceus, a symbol often associated with healthcare.
Public Health Service
- 8 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reprocessing Products Corporation c/o Mr. Wally Jansen President MedReg Consulting 8662 Comstock Lane N MAPLE GROVE MN 55311
Re: K090338
Trade/Device Name: Ultra Low Total Chlorine (K100-0118) and E-Z Check® Sensitive Total Chlorine (K100-0106) Test Strips Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: MSY Dated: February 6, 2009 Received: February 24, 2009
Dear Mr. Jansen:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at onc of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090338
Device Name:
Ultra Low Total Chlorine (K100-0118) and E-Z Check ® Sensitive Total Chlorine (K100-0106) Test Strips
Indications For Use:
The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Colin A. Pollard
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devi 510(k) Number