WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE

K953854 · Integrated Biomedical Technology, Inc. · FKP · Mar 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K953854
• Device Name: WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
• Applicant: Integrated Biomedical Technology, Inc.
• Product Code: FKP · Gastroenterology, Urology
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

WaterCheck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.

Device Story

WaterCheck™ CP is a paper-based dry chemistry reagent strip; consists of a single 0.2x0.2 inch reagent pad adhered to a 0.2x2.5 inch plastic handle. Device functions as a dip-and-read test; requires no additional reagents. Principle of operation: oxidation of 3,3',5,5'-tetramethylbenzidine (TMB) indicator. For chlorine detection, TMB turns blue at low levels (0.5 ppm) and brown at high levels (1000 ppm). For peroxide detection, catalytic oxidation of TMB detects hydrogen/acetyl peroxide at 0.5 ppm. Used in clinical dialysis settings to ensure water safety and verify disinfection solution efficacy. Healthcare providers visually compare strip color change to determine presence and concentration of analytes, facilitating decisions regarding water quality and disinfection adequacy.

Clinical Evidence

Bench testing only. Performance compared to predicate devices demonstrated equal effectiveness in detecting 0.5 ppm chlorine and 1.0 ppm hydrogen peroxide, with superior sensitivity (0.5 ppm) and room-temperature stability for peroxide detection.

Technological Characteristics

Paper-based dry chemistry reagent strip. Reagent: 3,3',5,5'-tetramethylbenzidine (TMB). Form factor: 0.2x0.2 inch pad on 0.2x2.5 inch plastic handle. Sensing principle: colorimetric oxidation-reduction reaction. No energy source required. Standalone device.

Indications for Use

Indicated for detection of residual chlorine or peroxide in dialysis water and for detection of effective high levels of chlorine in disinfecting solutions.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Serim Residual Chlorine Strip
• Renalin Residual Test Strips

Submission Summary (Full Text)

{0}

MAR 11 1996

integrated biomedical technology,inc.

K953854

PHONE [phone]

FAX [phone]

New 24-Hour Fax Number: [phone]

# 510(k) SUMMARY

WaterCheck™ CP

Reagent Strip for Chlorine and Peroxide

## SUMITTER:

Name: Wen H. Wu, Ph. D.
Address: 51819 Winding Waters Lane
Elkhart, IN 46514
Phone: [phone]
Fax: [phone]
Contact: Wen H. Wu, Ph. D.

Date Prepared: August 23, 1995

## DEVICE NAME:

Trade Name: WaterCheck™ CP
Common Name: Reagent Strip for Chlorine and Peroxide
Classification Name:

## COMPARATIVE PRODUCTS:

Serim Residual Chlorine Strip - Manufactured and marketed by Serim Research Corporation, Elkhart, IN 46514
Renalin Residual Test Strips - Marketed by Renal Systems, Minneapolis, MN 55447

## DESCRIPTION OF THE NEW DEVICE:

WaterCheck™ CP Reagent Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. The chemistry of the reagent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.

51819 WINDING WATERS LANE, ELKHART, INDIANA 46514

CONTRACT R&D / MANUFACTURING

{1}

Integrated Biomedical Technology, Inc.
510(k) Summary - WaterCheck™ CP
Elkhart, IN 46514-1644
Page 2

# INTEDED USE:

WaterCheck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.

# TECHNOLOGICAL COMPARISON:

For reaction with chlorine, both WaterCheck™ CP and Serim Residual Chlorine Strips are based on oxidation of a chromogenic indicator by chlorine. In Serim Strip, redox indicator, syringaldazine, is used in the strip formulation and it will turn purplish red when dip in chlorine solution. In WaterCheck™ CP strip, the redox indicator used is 3,3'5.5'-tetramethylbenzidine (TMB). The strip will turn blue in the presence of low level of chlorine. Both strips can detect chlorine level at 0.5 ppm or less. Since TMB will turn brown at a higher oxidation state, WaterCheck™ CP has also utilized this color shift to extended its detection range to high level of chlorine, 1000 ppm or more, where effective chlorine level is used for disinfection.

For reaction with peroxide, both WaterCheck™ CP and Renalin Test Strips are based on catalytic oxidation of 3,3'5,5'-tetramethylbenzidine (TMB) by hydrogen peroxide and acetyl peroxide. Both strips will detect as low as 1 ppm of hydrogen peroxide. WaterCheck™ CP, however, is stable at room temperature and is sensitive to 0.5 ppm or less of hydrogen peroxide. On the other hand, Renalin Test Strip requires refrigeration and is practically insensitive to 0.5 ppm of hydrogen peroxide.

# SUBSTANTIAL EQUIVALENCE STATEMENT:

Both WaterCheck™ CP and Serim Residual Chlorine Strips are equally effective in detecting 0.5 ppm or less of residual chlorine. WaterCheck™ CP can further detect high level, 1000 ppm or more, of chlorine in disinfecting solution.

Both WaterCheck™ CP and Renalin Test Strip are equally effective in detecting 1.0 ppm of hydrogen peroxide. WaterCheck™ CP, however, is more effective over Renalin Strip in that WaterCheck™ CP is stable at room temperature and is sensitive to 0.5 ppm or less of hydrogen peroxide.

Submitter: Wen H. Wu, Ph. D.
Date: Aug 23 95