STERICHEK CHLORINE REAGENT STRIPS

K971598 · Environmental Test Systems, Inc. · MSY · Jul 18, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971598
• Device Name: STERICHEK CHLORINE REAGENT STRIPS
• Applicant: Environmental Test Systems, Inc.
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

SteriChek TM Chlorine Reagent Strips provide a convenient means for measuring the concentration of chlorine bleach remaining in water being used to rinse out dialysate lines following disinfection of hemodialysis equipment.

Device Story

SteriChek Chlorine Reagent Strips consist of a chemically treated reagent pad affixed to a polystyrene strip. The device is used to detect residual chlorine bleach in water used to rinse hemodialysis equipment after disinfection. The user dips the strip into the rinse water; the reagent pad (containing syringaldazine, potassium iodide, and a pH buffer) reacts with free and combined chlorine (monochloramines) to produce a color change. The user compares the pad color to calibrated blocks on the label to estimate chlorine concentration in parts per million (ppm). A 5-second immersion provides a rapid screen for levels above 0.5 ppm; a 30-second immersion allows quantitative estimation between 0 and 5 ppm. This visual output assists healthcare providers in verifying that disinfection chemicals have been adequately rinsed from hemodialysis lines, ensuring patient safety during subsequent dialysis procedures.

Clinical Evidence

No clinical data provided; device relies on chemical reagent performance and comparison to established predicate device.

Technological Characteristics

Reagent pad containing syringaldazine, potassium iodide, and pH buffer on a 3.25 x 0.20 inch opaque polystyrene strip. Colorimetric detection principle. Visual comparison to label-based color blocks. Manual operation.

Indications for Use

Indicated for measuring residual chlorine bleach concentration in rinse water for hemodialysis equipment dialysate lines following disinfection.

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 Chlorine Reagent Strips

Submission Summary (Full Text)

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## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

JUL 18 1997

| Prepared: | April 29, 1997 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, Research |
| Device: | |
| | Trade/Proprietary Name: SteriChek ^TM Chlorine Reagent Strips |
| | Common/Usual Name: Test Strip for Chlorine in water |
| Classification Name: | Class II<br>CH |
| Predicate Device: | Serim ^TM Chlorine Reagent Strips<br>Manufactured by Environmental Test Systems, Inc. (for Serim Research Corporation) |
| 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. |
| Intended Use: | SteriChek ^TM Chlorine Reagent Strips provide a convenient means for<br>measuring the concentration of chlorine bleach remaining in water being used<br>to rinse out dialysate lines following disinfection of hemodialysis equipment. |
| Technological<br>Characteristics: | The concentration of chlorine in rinse water is obtained by comparing the<br>color of the reagent pad with color blocks on the label. The color blocks are<br>calibrated in terms of chlorine concentration in parts per million (ppm). The<br>device is used as either a 5 second rapid screening method to detect levels<br>above 0.5 ppm, or as a 30 second quantitative method to allow estimation of<br>chlorine concentrations between 0 and 5 ppm. |

SteriChek^TM Chlorine Reagent Strips contain syringaldazine, a colorless
compound which serves as an indicator, potassium iodide, and a pH buffer.

The reagent strips react with both free chlorine and combined chlorine

长971698

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510(k) Safety and Effectiveness Summary SteriChek™ Chlorine Reagent Strips Environmental Test Systems Page 2 of 2

(monochloramines). Free chlorine oxidizes syringaldazine to form a colored oxidation product. Combined chlorine in the form of monochloramines oxidize potassium iodide to iodine which in turn oxidizes syringaldazine to the colored form.

The predicate device has been manufactured by Environmental Test Performance: Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Chlorine Reagent Strips using the same bill of materials and the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name.

Assessment of

The SteriChek™ Chlorine Reagent Strips have the same intended use as Conclusion: the predicate device. There will be no changes in the design, materials, or other features compared to the predicate device, other than a change in the trade or proprietary name of the device. The SteriChekTM Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 18 1997

Re: K971598

David A. Morris, Ph.D. Vice President, Research Environmental Test Systems, Inc. P.O. Box 4659 Elkhart, Indiana 46514-0659

SteriChek™ Chlorine Reagent Strips ... ..... Dated: May 1, 1997 Received: May 2, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 78 MSY

Dear Dr. Morris:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified 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 practice, labeling, 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drue 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 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 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" (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 hap://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

h7liau Yu
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

Device Name: SteriChekTM Chlorine Reagent Strips.

## Indications for Use:

SteriChek™ Chlorine Reagent Strips provide. a convenient means for measuring the concentration of chlorine bleach remaining in water being used to rinse out dialysate lines following disinfection of hemodialysis equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Allung

(Division Sign-Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971598

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use