STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

K974798 · Environmental Test Systems, Inc. · LIF · Mar 20, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974798
• Device Name: STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
• Applicant: Environmental Test Systems, Inc.
• Product Code: LIF · Gastroenterology, Urology
• Decision Date: Mar 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

SteriChek™ Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid. The chemically treated pad changes color relative to the amount of peroxide remaining in the rinse.

Device Story

Device consists of 0.20 sq inch reagent pad on 3.25 inch opaque polystyrene strip. Pad contains 4-aminoantipyrine (4AAP), 8-amino-2-naphthalene sulfonic acid (ANS), peroxidase, and pH buffer. Input is rinse water from dialysate lines/dialyzers. Peroxidase catalyzes reaction between peroxide and indicators, producing red-purple color proportional to peroxide concentration. User compares pad color to calibrated label blocks (0-10 ppm). Used as rapid screen (<1.0 ppm) or quantitative estimate. Benefits patient by ensuring removal of residual peroxide post-disinfection.

Clinical Evidence

No clinical data. Bench testing only; performance verified by comparing reagent pad color development to calibrated color blocks representing known peroxide concentrations.

Technological Characteristics

Polystyrene strip with chemically treated reagent pad. Indicator system: 4-aminoantipyrine (4AAP) and 8-amino-2-naphthalene sulfonic acid (ANS) with peroxidase and pH buffer. Colorimetric detection method. Dimensions: 3.25 inch x 0.20 inch strip; 0.20 sq inch pad.

Indications for Use

Indicated for measuring residual peroxide concentration in rinse water for dialysate lines and dialyzers post-disinfection with peroxide/peracetic acid.

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™ Peroxide Reagent Strips

Submission Summary (Full Text)

{0}------------------------------------------------

Page 1/2

Image /page/0/Picture/1 description: The image shows the logo for ETS, which stands for Educational Testing Service. The logo is in black and white and features the letters "ETS" in a bold, stylized font. There are two horizontal lines above and below the letters.

Environmental Test Systems, Inc.

PInz

¥974798

## MAR 20 1998

510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | December 12, 1997 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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™ Residual Peroxide Reagent Strips |
| Device Common<br>Name: | ETS Peroxide Reagent Strips |
| Classification Name: | Class II<br>CH |
| Predicate Device: | Serim™ Peroxide Reagent Strips<br>Manufactured by Environmental Test Systems, Inc. (for Serim<br>Research Corporation) |
| Device Description: | The device is made up of a 0.20 square inch off-white reagent pad that<br>is chemically treated to detect peroxide in water. The pad is affixed to<br>one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. |
| Intended Use: | SteriChek™ Peroxide Reagent Strips provide a convenient means for<br>measuring the concentration of peroxide remaining in water being<br>used to rinse out dialysate lines and dialyzers following disinfection<br>with peroxide/peracetic acid. The chemically treated pad changes<br>color relative to the amount of peroxide remaining in the rinse. |

C2

{1}------------------------------------------------

K974798
P2012

Page 2/2

SteriChek Residual Peroxide Reagent Strips 510(k) Safety and Effectiveness Summary - December 12, 1997 Environmental Test Systems, Inc. (Page 2 of 2)

The concentration of peroxide in rinse water is obtained by comparing Technological the color of the reagent pad with color blocks on the label. The color Characteristics: blocks are calibrated in terms of peroxide concentration in parts per million (ppm). The device is used as a rapid screening method to detect levels of less than 1.0 ppm, or as a quantitative method to allow estimation of peroxide concentration between 0 and 10 ppm.

> SteriChek™ Peroxide Reagent Strips contain 4-Residual aminoantipyrine (4AAP) and 8-amino-2-naphthalene sulfonic acid (ANS), two colorless compounds which serve as the indicator system, peroxidase and a pH buffer. The reaction of the indicator reagents with hydrogen peroxide is catalyzed by peroxidase. This reaction of the indicators gives rise to a red-purple color. The intensity of the color is proportional to the concentration of the peroxide.

Assessment of The predicate device has been manufactured by Environmental Test Systems, Inc. since its introduction by Serim Research Corporation. Performance: ETS will manufacture the SteriChek™ Residual Peroxide Reagent Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follows the same test principles as the predicate device.

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

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 20 1998

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

Re: K974798

SteriChek™ Residual Peroxide Reagent Strips Dated: December 19, 1997 Received: December 22, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 LIF

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 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). 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 (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 (OS) 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 notification submission does not affect any obligation you might have under sections 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/cdrb/dsmamain.html".

Sincerely vours

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

{3}------------------------------------------------

SteriChek Residual Peroxide Reagent Strips 510(k) Submission - December 12, 1997 Environmental Test Systems, Inc.

510(k) Number (if known)

Device Name: SteriChek™ Residual Peroxide Regent Strips

## Indications for Use:

SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use | (Per 21 CFR 801.109)

Over-The Counter Use

OR