ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE

K090338 · Reprocessing Products Corp · MSY · May 8, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090338
• Device Name: ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
• Applicant: Reprocessing Products Corp
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: May 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

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.

Device Story

Device consists of reagent-impregnated test strip pad attached to plastic handle. User dips strip into water sample; chemical reagent reacts with Free Chlorine and Chloramines, causing color change. User compares resulting pad color against provided color charts to semi-quantitatively determine chlorine concentration. Used in clinical dialysis settings to monitor water quality for dialysate preparation and verify removal of residual chlorine from equipment after disinfection. Output allows healthcare providers to ensure water safety for dialysis procedures, preventing patient exposure to toxic chlorine levels.

Clinical Evidence

Bench testing only. Performance evaluated using reference solutions between 0 and 10 ppm chlorine. Data confirm color change correlates with reference solution concentrations, demonstrating accurate detection performance below, equal to, and above dialysis thresholds of 0.5 ppm (Free Chlorine) and 0.1 ppm (Total Chlorine/Chloramines).

Technological Characteristics

Semi-quantitative reagent test strip. Pad impregnated with chemicals reacting to Free Chlorine and Chloramines. Colorimetric detection via visual comparison to color charts. Standalone, non-electronic, single-use device.

Indications for Use

Indicated for detection of Free Chlorine and Total Chlorine in water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).

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

• SERIM® HISENSE ULTRA 0.1TM

Submission Summary (Full Text)

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Traditional 510k Premarket Notification Total Chlorine Test Strips

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MAY - 8 2009

# 510(k) SUMMARY

| Prepared: | February 6, 2009 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 3655 N. Oracle Road<br>Tucson, AZ 85705 |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | Two ranges:<br>Ultra Low Total Chlorine (K100-0118) and<br>E-Z Chek® Sensitive Total Chlorine<br>(K100-0106) Test Strips |
| Common or Usual Name: | Total Chlorine Test Strips |
| Device Classification Name: | Strip, Test, Reagent, Residuals for<br>Dialysate, Disinfectant |
| Product Code: | MSY |
| Class: | II |
| Regulation Number: | 875.5665 |
| Substantial Equivalence: | The RPC Total Chlorine Test Strips are<br>substantially equivalent to the SERIM®<br>HISENSE ULTRA 0.1TM |
| Device Description: | Device is semi-quantitative, reagent test<br>strip comprised of a pad impregnated with<br>chemicals which change color upon contact<br>with Free Chlorine or Chloramines. The<br>pad is attached to a plastic strip for<br>handling. |
| Intended Use: | The RPC Total Chlorine Test Strips are<br>indicated for use in the monitoring of<br>chlorine in water used to prepare dialysate<br>and water used to rinse dialysis equipment. |
| Technological Characteristics: | The Test Strips will detect chlorine<br>concentrations equal to, above and below<br>0.1 ppm for Total Chlorine in water used to<br>prepare dialysate and 0.5 ppm for Free<br>Chlorine in dialysis equipment rinse water.<br>The test strip pad contains a specialized<br>chemical reagent that reacts with Free<br>Chlorine and Chloramines in water. The<br>reaction results in a color change which is<br>correlatable to the concentration of chlorine<br>in the test water |

This document contains information considered CONFIDENTIAL to Reprocessing Products Corporation

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Traditional 510k Premarket Notification Total Chlorine Test Strips

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| 090338 | 262 |
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| cation<br>Strips | |

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| Page 2 of 2 | The color change is interpreted by the use<br>of color blocks on two separate (ranges)<br>color charts. Gradations for the Ultra-Low<br>Total Chlorine (K100-0118) color chart<br>include 0 ppm, 0.01 ppm, 0.02 ppm,<br>0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm.<br>Gradations for the E-Z Chek® Sensitive<br>Total Chlorine (K100-0106) color chart<br>include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0<br>ppm. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance: | The data confirm the product consistently<br>generates color change which correlates<br>with the color block for the Reference<br>solution concentration. Reference<br>solutions were used to evaluate<br>performance between 0 and 10 ppm<br>Chlorine. These data demonstrate accurate<br>detection performance, below, equal to, and<br>above the dialysis level of 0.5 ppm for Free<br>Chlorine and below, equal to, and above<br>the dialysis level of 0.1 ppm for<br>Chloramines (measured as Total Chlorine).<br>These data demonstrate appropriate<br>performance for use in testing dialysis<br>equipment rinse water and for testing water<br>for dialysate preparation. |
| Conclusion: | The RPC Total Chlorine Test Strips have<br>the same intended use as the predicate<br>device. Both test strips measure total<br>chlorine (free chlorine/chloramines) levels<br>in water. The RPC Total Chlorine Test<br>Strips have no characteristics which raise<br>new types of safety and effectiveness<br>questions. The RPC Total Chlorine Test<br>Strips can be used to monitor the level of<br>total chlorine (free chlorine/chloramines)<br>present in water used for preparation of<br>dialysate. The test strips can also be used to<br>detect residual chlorine levels in rinse<br>water from dialysis equipment after<br>disinfection. |

This document contains information considered CONFIDENTIAL to Reprocessing Products Corporation

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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 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.

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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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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

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K090338

## 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