STERICHEK TOTAL CHLORINE REAGENT STRIPS

K994226 · Environmental Test Systems, Inc. · MSY · Mar 22, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994226
• Device Name: STERICHEK TOTAL CHLORINE REAGENT STRIPS
• Applicant: Environmental Test Systems, Inc.
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: Mar 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

SteriChek™ Total Chlorine Reagent Strips provide 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 color that develops in the pad after exposure to the sample according to the directions is compared to a color chart to determine the concentration of total chlorine present in the sample.

Device Story

Device consists of 0.20-inch square reagent pad affixed to 3.25-inch by 0.20-inch opaque polystyrene strip. Pad contains Michler's thioketone indicator and activating surfactant. User exposes pad to water sample; free and combined chlorine react with indicator to form blue complex. User visually compares pad color to calibrated color chart on label to quantify total chlorine concentration (0 to 3 ppm range; 0.1 ppm sensitivity). Used in clinical settings for water quality monitoring during dialysate preparation. Provides rapid, quantitative assessment of chlorine levels to ensure water safety for dialysis.

Clinical Evidence

Bench testing only. Performance analyzed using water samples spiked with sodium hypochlorite or chloramines across a range of free and combined chlorine levels. Performance demonstrated to be equivalent to the predicate device.

Technological Characteristics

Reagent pad on polystyrene strip. Indicator: Michler's thioketone. Sensing principle: colorimetric chemical reaction forming blue complex proportional to chlorine concentration. Range: 0-3 ppm. Sensitivity: 0.1 ppm. Visual readout via color chart.

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 Kit

Submission Summary (Full Text)

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994226 p. i/2

MAR 2 2 2000

SteriChek™ Total Chlorine Reagent Strips 510(k) Submission Environmental Test Systems, Inc.

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | December 10, 1999 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Environmental Test Systems, Inc. |
| Address: | 23575 County Road 106<br>Elkhart, IN 46514<br>U.S.A.<br>[phone] |
| Contact: | David A. Morris, Ph.D.<br>Vice President, Technology |
| Device Trade/Proprietary Name: | SteriChek ^™ Chlorine Reagent Strips |
| Device Common Name: | Total Chlorine Reagent Strips |
| Classification Name: | Class II CH |
| Predicate Device: | Serim ^™ HiSense Test Kit |
| Device Description: | The device is made up of a 0.20 inch square off-white reagent pad that has<br>been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch<br>white opaque polystyrene strip. The reagent pad is activated by exposing<br>it to the sample. The color of the pad is visually compared to a color chart<br>to determine the amount of total chlorine present in the sample. |
| Intended Use: | SteriChek ^™ Total Chlorine Reagent Strips provide a quick convenient<br>means of testing for low levels of total chlorine (i.e. total chloramines plus<br>free chlorine) in water used to prepare dialysate. The color that develops<br>in the pad after exposure to the sample according to the directions is<br>compared to a color chart to determine the concentration of total chlorine<br>present in the sample. |
| Technological Characteristics: | The concentration of chlorine in rinse water is obtained by comparing the |

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K994226 p.2/2

MAR 2 2 2000

SteriChek™ Total Chlorine Reagent Strips 510(k) Submission Environmental Test Systems, Inc.

color of the reagent pad with color blocks on the label. The color blocks are calibrated in terms of chlorine concentration in parts per million (ppm). The device is used as a quantitative method to detect total chlorine concentrations between 0 and 3 ppm. The device will reliably measure total chlorine concentrations as low as 0.1 ppm total chlorine.

SteriChek™ Chlorine Reagent Strips contains an indicator, Michler's thioketone, an activating surfactant, and other non-reactive ingredients. Free chlorine and combined chlorine (chloramines) react with the indicator to form a blue complex. The amount of the blue complex is dependent on the concentration of free chlorine and combined chlorine in the sample.

Assessment of Performance:

The performance characteristics of SteriChek™ Total Chlorine reagent Strips Serim™ and HiSense Test Kit were analyzed with water samples in which either sodium hypochlorite or chloramines were added to give a range of free chlorine or combined chlorine levels. The performance was equivalent.

Conclusion: The SteriChek™ Total Chlorine Reagent Strips have the same intended use as the predicate device. The predicate device's indicator system (qualitative combined dry and liquid colorimetric method) is different than that of the Total Chlorine Reagent Strips. However, both systems effectively measure the total free and combined chlorine levels in water. The SteriChek™ Total Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.

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Public Health Service

MAR 2 2 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David A. Morris, Ph.D. Vice President, Technology Environmental Test Systems, Inc. 23575 County Road, #106 Elkhart, IN 46514

Re: K994226 SteriChek™ Total Chlorine Reagent Strips Dated: March 1, 2000 Received: March 6, 2000 Requiatory Class: II 21 CFR \$876.5665/Procode: 78 MSY

Dear Dr. Morris:

We have reviewed your Section 510K) notification of intent to market the device 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 reclassfied in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 regulation (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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or requlations.

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 market predication 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 question 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" (21CFR 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,

Daniel G. Schultz, M.D. Captain, USPHS Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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SteriChek™ Total Chlorine Reagent Strips 510(k) Submission Environmental Test Systems, Inc.

510(k) Number (if known) K994336

Device Name: SteriChek™ Total Chlorine Reagent Strips.

## Indications for Use:

:

SteriChek™ Total Chlorine Reagent Strips provide 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)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Dev 510(k) Number

Over-The-Counter Use

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