STERICHEK TOTAL CHLORINE TEST KIT

K983997 · Environmental Test Systems, Inc. · MSY · Apr 2, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983997
• Device Name: STERICHEK TOTAL CHLORINE TEST KIT
• Applicant: Environmental Test Systems, Inc.
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The water sample changes color relative to the amount of total chlorine in the water sample.

Device Story

Device is a colorimetric test kit for measuring total chlorine in water used for dialysate preparation. Input: water sample mixed with powdered reagent (DPD and potassium iodide) in a test tube. Principle: Chlorine oxidizes DPD to magenta; chloramines oxidize potassium iodide to iodine, which then oxidizes DPD to magenta. Output: visual color intensity compared against a calibrated colorimetric comparator (0–0.7 ppm). Used by clinical staff in dialysis settings to ensure water quality. Results inform clinical decisions regarding water safety for dialysate preparation, potentially preventing patient exposure to chlorine/chloramines.

Clinical Evidence

Bench testing only. Performance compared against predicate device using water samples spiked with sodium hypochlorite or monochloramines to create a range of free and combined chlorine concentrations. Results showed equivalent performance between the SteriChek kit and the predicate.

Technological Characteristics

Colorimetric test kit using powdered reagent (DPD and potassium iodide) and pH buffer. Quantitative measurement range 0–0.7 ppm. Visual color comparison against calibrated comparator. Complies with ANSI/AAMI RD5-1992 standard for total chlorine analysis in water.

Indications for Use

Indicated for testing low levels of total chlorine (total chloramines and free chlorine) in water used to prepare dialysate.

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 Test Strips

Submission Summary (Full Text)

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K983997 p.1/2

Image /page/0/Picture/1 description: The image shows the SteriChek logo with the words "REAGENT STRIPS" underneath. The word "SteriChek" is in large, bold, black letters with a white outline. The words "REAGENT STRIPS" are in smaller, black letters. Above the logo is a handwritten date of 4/2/99.

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | November 5, 1998 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Environmental Test Systems, Inc. |
| Address: | 23575 County Road 106<br>Elkhart, IN 46514-0659<br>U.S.A.<br>[phone] |
| Contact: | Bruce G. Piekarski, Director-Business Development |
| Device Trade/<br>Proprietary Name: | SteriChek™ Total Chlorine Test Kit |
| Device Common<br>Name: | ETS DPD Chlorine Test Kit |
| Classification Name: | Class II<br>CH |
| Predicate Device: | Serim™ HiSense Test Strips |
| Device Description: | The device consists of utilizing a fixed sample size of powdered<br>reagent with a predetermined water sample volume in a test tube to<br>effect a color reaction in the water sample. The color of the sample is<br>then visually compared to a colormetric comparator to determine the<br>total chlorine level in the sample. The device utilizes a recognized<br>standard method of analysis for determining levels of total chlorine in<br>water according to the Association for the Advancement of Medical<br>Instrumentation (1993 Association for the Advancement of Medical<br>Instrumentation-ANSI/AAMI;RD5-1992). |
| Intended Use: | SteriChek™ Total Chlorine Test Kit provides a quick convenient<br>means of testing for low levels of total chlorine (i.e. total chloramines<br>plus free chlorine) in water used to prepare dialysate. The water<br>sample changes color relative to the amount of total chlorine in the<br>water sample. |

## Simply Accurate

Environmental Test Systems, Inc. • 102 Box 4659 • Elkhart, Indiana 46514-0659 219-262-2060 • Fax [phone] • 1-888-ETS-STRIps (1-888-387-7874) • www. etsstrips.com

ISO 9001 Certified

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## SteriChek™ Total Chlorine Test Kit 510(k) Safety and Effectiveness Summary - November 5, 1998 Environmental Test Systems, Inc. (Page 2 of 2)

The concentration of total chlorine in water is obtained by comparing the Technological color of the water sample mixed with the powdered reagent to the color Characteristics: comparator. The color comparator is calibrated in terms of total chlorine concentration in parts per million (ppm). The device is used as a quantitative method to detect total chlorine concentrations between 0 and 0.7 ppm.

> SteriChek™ Total Chlorine Test Kit contains DPD and potassium iodide that serves as the indicator system and a pH buffer. Chlorine oxidizes DPD (a colorless compound) to form a magenta (red) color. Chloramines oxidize potassium iodide to iodine, which oxidizes DPD to form the magenta color. The intensity of the color is proportional to the concentration of total chlorine (chloramines and free chlorine).

The performance characteristics of the predicate device was analyzed Assessment of Performance: with water samples in which either sodium hypochlorite or monochloramines were added to give a range of free chlorine or combined chlorine levels (See Predicate Device "Product Insert"). The SteriChek™ Total Chlorine Test Kit was also analyzed with samples in which either sodium hypochlorite or monochloramines were added to give a range of free chlorine or combined chlorine levels. Performance of both devices was equivalent.

The SteriChek™ Total Chlorine Test Kit has the same intended use as Conclusion: the Predicate Device. The predicate device's indicator system (qualitative combined dry and liquid reagent colorimetric method) is different than SteriChek™ Total Chlorine Test Kit (quantitative powdered reagent colorimetric method). However, SteriChek™ Total Chlorine Test utilizes the recognized standard method of analysis of the Association for the Advancement of Medical Instrumentation. In fact, the SteriChek™ Total Chlorine Test Kit has no technological characteristics that raise new types of safety or effectiveness questions.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1999

Mr. Bruce G. Piekarski Director - Business Development Environmental Test Systems, Inc. P.O. Box 4659 Elkhart, IN 46514-0659

Re: K983997

SteriChek™ Total Chlorine Test Kit Dated March 5, 1999 Received: March 8, 1999 Regulatory Class: II 21 CFR 876.5665/Procode: 78 MSY and 78 FIP

Dear Mr. Piekarski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dan Setiz
BART Daniel G. Seitel, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The text is in all caps and is evenly spaced around the circle.

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SteriChekTM Total Chlorine Test Kit 510(k) Submission - November 5, 1998 Environmental Test Systems, Inc.

510(k) Number (if known)

Device Name: SteriChek™ Total Chlorine Test Kit

Indications for Use:

SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines and free chlorine) in water used to prepare dialysate.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

7

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | OR |
|----------------------|----------------------------------------------------------------|----|
| (Per 21 CFR 801,109) | | |

*Signature*

on Sign-Off)

sion of Reproductive, Abdominal, ENT,

• Radiological Devices

| 10(k) Number | K983997 / 5004 |
|--------------|----------------|
|--------------|----------------|

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________