STERICHEK PERACETIC ACID REAGENT STRIPS

K980164 · Environmental Test Systems, Inc. · MSY · Apr 16, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980164
• Device Name: STERICHEK PERACETIC ACID REAGENT STRIPS
• Applicant: Environmental Test Systems, Inc.
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

SteriChek Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing. The chemically treated pad changes color relative to the amount of peracetic acid in the dialyzer reprocessing mix.

Device Story

Device consists of reagent-treated pad on polystyrene strip; used to detect peracetic acid concentration in dialyzer reprocessing solutions. User dips strip into solution; chemical reaction between peracetic acid, starch, potassium iodide, and pH buffer oxidizes iodide to iodine; forms gray/purple or black color indicating acceptable levels; absence of color indicates insufficient levels. Visual comparison of color change after 10 seconds allows clinician to verify reprocessing efficacy. Benefits patient by ensuring dialyzers are properly disinfected before reuse.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reagent pad containing starch, potassium iodide, and pH buffer affixed to 3.25 x 0.20 inch white opaque polystyrene strip. Sensing principle: chemical oxidation-reduction reaction resulting in colorimetric change. Standalone, non-electronic, visual-read device.

Indications for Use

Indicated for determining effective peracetic acid levels during dialyzer reprocessing in hemodialysis settings.

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™ Peracetic Acid Reagent Strips

Submission Summary (Full Text)

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

K980164

APR 1 6 1998

-----

Image /page/0/Picture/2 description: The image shows the logo for Environmental Test Systems, Inc. The logo consists of the letters "ETS" in a bold, stylized font. The letters are black and have a thick, horizontal line above and below them. Below the logo, the words "Environmental Test Systems, Inc." are printed in a smaller, regular font.

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | January 15, 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™ Peracetic Acid Reagent Strips |
| Device Common<br>Name: | ETS Peracetic Acid Reagent Strips |
| Classification Name: | Class II<br>CH |
| Predicate Device: | Serim™ Peracetic Acid 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 inch square faint-yellow reagent pad that<br>has been chemically treated to detect peracetic acid in dialyzer<br>reprocessing mix. The pad is affixed to one end of a 3.25 inch by 0.20<br>inch white opaque polystyrene strip. |
| Intended Use: | SteriChek Peracetic Acid Reagent Strips provide a convenient means for<br>determining the effective levels of peracetic acid in dialyzer<br>reprocessing. The chemically treated pad changes color relative to the<br>amount of peracetic acid in the dialyzer reprocessing mix. |

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

98064

## SteriChek Peracetic Acid Reagent Strips 510(k) Safety and Effectiveness Summary - January 15, 1998 Environmental Test Systems, Inc. (Page 2 of 2)

The concentration of peracetic acid in dialyzer reprocessing is obtained Technological Characteristics: by observing the absence or concentration of color. None or minimal color after 10 seconds indicates insufficient levels of peracetic acid and dark color (gray/purple) or black indicates acceptable levels of peracetic acid.

> SteriChek™ Peracetic Acid Reagent Strips contain starch, potassium iodide and a pH buffer. When reacted with peracetic acid, the iodide is oxidized to iodine, forming a gray/purple color with starch.

The predicate device has been manufactured by Environmental Test Assessment of Performance: Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Peracetic Acid 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 follow the same test principles as the predicate device.

Conclusion: The SteriChek™ Peracetic Acid Reagent Strips have the same 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 a change in color development and the trade or proprietary name of the The SteriChek™ Peracetic Acid Reagent Strips have no device. technological characteristics that raise new types of safety or effectiveness questions.

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

Image /page/2/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

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

Re: K980164

SteriChek™ Peracetic Acid Reagent Strips Dated: January 15, 1998 Received: January 16, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 MSY & 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 equivalion 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 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/cdrh/dsmaldsmamain.html".

Sincerely yours

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 Peracetic Acid Reagent Strips 510(k) Submission - January 15, 1998 Environmental Test Systems, Inc.

510(k) Number (if known)

Device Name: SteriChek™ Peracetic Acid Regent Strips

## Indications for Use:

. ・

--

SteriChek™ Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing in hemodialysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roler R. Ratluy
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number. (98-0164

.

Prescription Use レ (Per 21 CFR 801.109)

OR

Over-The Counter Use